Lilly, Merck & Co., and Mylan Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Merck & Co and Mylan.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday January 11, 2017 to Tuesday January 17, 2017.

Lilly’s Rheumatoid Arthritis Drug Review Delayed
Eli Lilly and Company and Incyte Corporation, a Wilmington, Delaware-based biopharmaceutical company, have received notification from the US Food and Drug Administration that the agency has extended the review period for the new drug application (NDA) for investigational baricitinib, a drug for treating rheumatoid arthritis (RA).

The FDA extended the action date in order to review additional data analyses recently submitted by Lilly in response to the FDA’s information requests. The FDA determined that the additional information submitted constitutes a major amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.

Baricitinib is a once-daily oral Janus kinase inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The NDA for baricitinib, which is seeking approval of the drug for treating moderate to severe RA, was submitted to the FDA in January 2016.

Lilly and Incyte entered into an exclusive worldwide license and collaboration agreement in December 2009 to develop and commercialize baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of RA in the US, European Union, and Japan in the first quarter of 2016. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion in December 2016, recommending the approval of baricitinib. If approved, baricitinib would be marketed under the brand name Olumiant.

Baricitinib is also being studied in Phase II trials for treating atopic dermatitis and systemic lupus erythematosus, and a Phase III trial for treating psoriatic arthritis is expected to be initiated in 2017.

Source: Eli Lilly and Company


FDA Takes Merck & Co.’s Lung Cancer Indication Filing
Merck & Co.’s supplemental biologics license application (sBLA) for Keytruda (pembrolizumab) has been accepted by US Food and Drug Administration (FDA). Merck is seeking approval for Keytruda plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of programmed death (PD)-L1 expression and with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

This is the first application for regulatory approval of Keytruda in combination with another treatment. The FDA granted priority review with a Prescription Drug User Free Act, or target action, date of May 10, 2017. The sBLA will be reviewed under the FDA’s accelerated approval program.

Keytruda is currently approved in lung cancer for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; and for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS of one percent or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.

Merck has an extensive development program in NSCLC and is currently advancing multiple registration-enabling studies with Keytruda as monotherapy and in combination with other treatments. Some analysts project that Keytruda, which had 2015 sales of $566 million, will reach blockbuster status.

Source: Merck & Co.


FDA Accepts Mylan’s Filing for a Biosimilar of Roche’s Herceptin 
The US Food and Drug Administration (FDA) has accepted a biologics license application from Mylan and Biocon, a Bangalore, India-based biopharmaceutical company, for MYL-1401O, a proposed biosimilar trastuzumab, the active ingredient in Roche’s breast-cancer drug, Herceptin (trastuzumab). The anticipated FDA goal-date set under the Biosimilar User Fee Act is Sept. 3, 2017.

Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA). Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand, and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Roche’s Herceptin is a top-selling drug with 2015 sales of CHF 6.538 billion ($6.470 billion).

Source: Mylan

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