Eli Lilly’s Humulin R U-500 KwikPen Gets FDA Approval

January 21, 2016: Eli Lilly and Co gets FDA approval of Humulin R U-500 KwikPen. The FDA approved HumulinR U-500 KwikPen (insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.

More Eli Lilly News

December 28, 2015: Leerink reiterates an Outperform rating on Eli Lilly and Co, and raises its price target to $95 from $93.

December 10, 2015: Eli Lilly announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck’s KEYTRUDA(pembrolizumab) in a Phase I study across multiple tumor types. Based on the Phase I trial results, the collaboration has the potential to progress to Phase II trials in patients who have been diagnosed with either metastatic breast cancer or non-small cell lung cancer (NSCLC).

Lilly is the sponsor of the Phase I study, and of any subsequent Phase II studies, per the terms of the agreement. Enrollment is scheduled to begin in early 2016. Financial details of the collaboration were not disclosed.

Lilly’s abemaciclib is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK4 and CDK6. Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

November 30, 2015: Eli Lilly and Co (LLY Updated Trend Analysis) Boehringer Ingelheim Ltd. and Eli Lilly Canada announced today that Health Canada has approved JARDIANCE (empagliflozin) to be used as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.

JARDIANCE belongs to a new class of agents called sodium glucose co-transporter 2 (SGLT2) inhibitors that have a different mechanism of action from other oral glucose-lowering agents. JARDIANCE lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.

November 24, 2015: Eli Lilly and Co receives FDA approval for Portrazza (necitumumab) in advanced squamous non-small cell lung cancer. The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer squamous cell and non-squamous cell (which includes adenocarcinoma). The safety and efficacy of Portrazza were evaluated in a multicenter, randomized, open-label clinical study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without Portrazza. Those taking Portrazza plus gemcitabine and cisplatin lived longer on average (11.5 months) compared to those only taking gemcitabine and cisplatin (9.9 months). Portrazza was not found to be an effective treatment in patients with non-squamous NSCLC. The most common side effects of Portrazza are skin rash and magnesium deficiency (hypomagnesemia), which can cause muscular weakness, seizure, irregular heartbeats and can be fatal. Portrazza includes a boxed warning to alert health care providers of serious risks of treatment with Portrazza, including cardiac arrest and sudden death, as well as hypomagnesemia.

November 24, 2015: Eli Lilly and Co FDA grants orphan designation for necitumumab for the treatment of squamous non-small cell lung cancer.

November 08, 2015: Eli Lilly and Co detailed results demonstrate Baricitinib superiority to Adalimumab in improving signs and Symptoms of rheumatoid arthritis. Eli Lilly and Company and Incyte Corporation today announced detailed data from pivotal phase 3 study RA-BEAM, the fourth successful phase 3 study of baricitinib, at the American College of heumatology/Association of Rheumatology Health Professionals annual meeting in San Francisco. The findings demonstrated statistical superiority for investigational therapy baricitinib over adalimumab (Humira(R) )* after 12 weeks based on several critical measures of rheumatoid arthritis (RA) disease activity, including ACR20, ACR50 and ACR70 response rates — composite scores that represent at least a 20%, 50% and 70% improvement in multiple components of RA disease activity.

November 08, 2015: Eli Lilly patients show significant improvement in signs and symptoms of Psoriatic Arthritis when Treated with Ixekizumab for 24 Weeks. Psoriatic arthritis (PsA) patients treated with ixekizumab for 24 weeks achieved significant improvements in signs and symptoms of their disease when compared to placebo, while also experiencing significantly less progression of radiographic structural joint damage, reduced disability when performing certain physical functions and improved skin clearance of plaque psoriasis.

Detailed results of the SPIRIT-P1 study were presented during the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Francisco. Ixekizumab is the company’s investigational medicine for the treatment of active PsA and moderate-to-severe plaque psoriasis.

“The SPIRIT-P1 data show that ixekizumab may be able to address unmet or underserved needs that many patients living with psoriatic arthritis have, including the reduction of painful and debilitating skin and joint inflammation, which are the hallmarks of this chronic disease,” said Philip Mease, M.D., chief of rheumatology research, Swedish Medical Center, and clinical professor, University of Washington, Seattle. Dr. Mease is a SPIRIT-P1 study investigator.

During the 24-week, double-blind period of this Phase 3 study, patients who had never received a biologic disease-modifying antirheumatic drug (bDMARD) were treated with either 80 mg of ixekizumab once every two weeks or every four weeks (following a 160 mg starting dose); adalimumab at the approved dose of 40 mg every other week; or placebo. Adalimumab was employed as an active control in the SPIRIT-P1 study and was not powered for comparison with ixekizumab treatment groups.

Significant Improvements in Disease Signs and Symptoms, Structural Joint Damage
In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements compared with placebo in disease activity of PsA as demonstrated by the proportion of patients achieving an ACR20 response at 24 weeks, the study’s primary objective. Improvements were experienced by ixekizumab-treated patients as early as one week after treatment initiation. ACR20 represents at least a 20 percent reduction in a composite measure of disease activity as defined by the ACR. Other measures included ACR50 and ACR70, which represent 50 percent and 70 percent reductions in disease activity.

At 24 weeks, 62 percent of patients treated every two weeks and 58 percent of patients treated every four weeks with ixekizumab achieved ACR20 compared with 30 percent of placebo-treated patients. The proportions of ixekizumab-treated patients who achieved ACR50 when treated every two weeks or every four weeks were 47 percent and 40 percent, respectively, compared with 15 percent of patients treated with placebo. Furthermore, 34 percent of patients treated with ixekizumab every two weeks and 23 percent of those treated every four weeks experienced a 70 percent reduction in disease activity. Six percent of patients treated with placebo achieved this level of improvement.

Patients treated with ixekizumab at both dosing regimens also experienced significantly less radiographic progression of structural joint damage than those treated with placebo, as measured by the change from baseline in the van der Heijde modified total Sharp score (mTSS) for PsA at 24 weeks. Structural joint damage caused by PsA may lead to permanent joint deformity and reduced physical function.

Reduced Disability in Physical Function, Improved Skin Clearance
Ixekizumab treatment groups also experienced significant improvements compared with placebo in other key secondary measures, including physical function as assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), and improved skin clearance of plaque psoriasis as measured by the Psoriasis Area and Severity Index (PASI), including PASI75, 90 and 100. A PASI75 score indicates at least a 75 percent reduction in a patient’s plaque psoriasis from the patient’s baseline assessment, while PASI90 reflects a 90 percent reduction and PASI100 represents a 100 percent reduction, reflecting complete skin clearance.

Efficacy results with adalimumab compared with placebo during the SPIRIT-P1 study were significant on most measures. At 24 weeks, 57 percent of patients treated with adalimumab, the study’s active control, achieved ACR20, while 39 percent and 26 percent achieved ACR50 and ACR70, respectively.

The incidence of treatment-emergent adverse events (TEAE) was greater with ixekizumab treatment compared with placebo. The most common (=4 percent) adverse events observed with ixekizumab treatment were injection site reaction, injection site erythema and nasopharyngitis. These events are consistent with those reported in the Phase 3 studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (UNCOVER 1, 2, 3). Serious adverse events and discontinuation rates due to adverse events were not significantly different between treatment groups.

“Many people living with this debilitating disease are still searching for an effective treatment,” said J. Anthony Ware, M.D., senior vice president, product development, Lilly Bio-Medicines. “These results further support our continuing investigation of ixekizumab for the treatment of psoriatic arthritis, and our belief that this investigational medicine may offer a viable choice in the future for people seeking a better way to manage their disease.”

About the SPIRIT-P1 Study
SPIRIT-P1 is a Phase 3 randomized, active- and placebo-controlled study examining the effect of ixekizumab compared with placebo in patients with active PsA who are bDMARD-nave. Patients were required to have an established diagnosis of PsA and active disease for at least six months. The trial included 417 patients (stratified 1:1:1:1 ratio for all treatment groups) with active psoriatic arthritis who had at least three tender and three swollen joints and the presence of at least one disease-related joint erosion of the hand or foot as seen on X-ray or a C-reactive protein (CRP) greater than 6 mg/L at screening. During the study, ixekizumab-treated patients received a starting dose of 160 mg administered subcutaneously (SC), as two 80 mg injections, followed by one of two dosing regimens: either 80 mg administered SC once every two weeks or 80 mg administered SC once every four weeks. Adalimumab at the approved dose of 40 mg SC and regimen of every other week was selected as the active control for comparison with placebo. The SPIRIT-P1 study will also evaluate the long-term efficacy and safety of ixekizumab in PsA for up to three years.

October 22, 2015: Eli Lilly and Co (LLY Updated Trend Analysis) and AstraZeneca expand immuno-oncology research collaboration with new combinations. Eli Lilly and Company and AstraZeneca announced an extension to their existing immuno-oncology collaboration exploring novel combination therapies for the treatment of patients with solid tumors. Under the terms of the expanded agreement, Lilly and AstraZeneca will evaluate the safety and efficacy of a range of additional combinations across the companies’ complementary portfolios. Lilly will lead the execution of the studies, while both companies will contribute resources. Additional details of the collaboration, including tumors to be studied and financial terms, were not disclosed. AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), will be combined with Lilly molecules that target the immune system, including:
– TGF-beta kinase inhibitor, galunisertib.
– CXCR4 peptide antagonist.
– An anti-CSF-1R monoclonal antibody, which will also be assessed with AstraZeneca’s anti-CTLA-4 monoclonal antibody, tremelimumab.
The companies will also explore other combinations targeting tumor drivers and resistance mechanisms, including:
– Lilly’s abemaciclib (CDK4 and 6 small molecule inhibitor) with Faslodex, AstraZeneca’s marketed selective estrogen receptor down regulator (SERD).
– Both CYRAMZA() (ramucirumab) and necitumumab, Lilly’s anti-VEGFR and anti-EGFR monoclonal antibodies, respectively, with AZD9291, AstraZeneca’s investigational third-generation EGFR inhibitor.

October 11, 2015: Eli Lilly and Co Lilly and Innovent Biologics Expand Their Strategic Alliance to Include Immuno-Oncology Bispecific Antibodies in China and Globally. Eli Lilly and Company and Innovent Biologics, Inc. (Innovent) today announced an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company. Below are details of the expanded agreement:
– The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
– Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China.
– Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
– Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed.
Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent.

October 12, 2015: Eli Lilly and Co to discontinue Phase 3 trial of evacetrapib due to insufficient efficacy; to take $0.05 charge in Q4. Eli Lilly has accepted the recommendation of the independent data monitoring committee to terminate the Phase 3 trial of the investigational medicine evacetrapib, due to insufficient efficacy. Lilly will discontinue development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease and will now conclude other studies in the program. The independent data monitoring committee based its recommendation on data from periodic data reviews, which suggested there was a low probability the study would achieve its primary endpoint based on results to date. The study is not being stopped for safety findings. After further analysis, results of the study will be presented in scientific forums in the future. “This unfortunate outcome for evacetrapib does not change our ability to generate long-term growth,” said Derica Rice, Lilly executive vice president and chief financial officer. “Our recent string of positive data-readouts and our strong pipeline position us to grow revenue and expand margins through the remainder of this decade.” The decision to discontinue development of evacetrapib is expected to result in a fourth-quarter charge to research and development expense of up to $90 million (pre-tax), or approximately $0.05 per share (after-tax). The company will incorporate this estimated charge into its updated 2015 guidance that will be provided as part of its third quarter 2015 earnings press release on Thursday, Oct. 22, 2015.

October 8, 2915: Eli Lilly receives FDA Breakthrough Therapy Designation for Abemaciclib CDK 4 and 6 Inhibitor. The FDA has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.

According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

“If caught before it spreads, patients can survive breast cancer. However, for the nearly 10 percent of patients who are initially diagnosed at stage IV, and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease, there remains an urgent need for effective therapy options,” said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. “We are pleased that the FDA has designated abemaciclib as a breakthrough therapy for patients with advanced breast cancer and Lilly will work closely with the FDA in this process to expedite its development and review.”

Lilly has an active clinical development program studying abemaciclib in breast cancer. MONARCH 1 is a Phase II trial evaluating the use of abemaciclib as monotherapy in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two Phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.

Eli Lilly (LLY Updated Trend Analysis) is a global healthcare company that creates high-quality medicines that meet needs. It operates through two segments, Human Pharmaceutical Products and Animal Health Products. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Follow me

Lance Jepsen

For ethical purposes, I try not to hold any position in any stock I profile on GuerillaStockTrading.com unless specifically stated in the article. Owner of GuerillaStockTrading.com. Seasoned entrepreneur, investor, and writer. I love God, family, country, stock trading, economics, and helping people learn how to trade.
Follow me

Author: Lance Jepsen

For ethical purposes, I try not to hold any position in any stock I profile on GuerillaStockTrading.com unless specifically stated in the article. Owner of GuerillaStockTrading.com. Seasoned entrepreneur, investor, and writer. I love God, family, country, stock trading, economics, and helping people learn how to trade.

Leave a Reply