Amgen and Lilly Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Amgen and Lilly.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday February 8, 2017 to Tuesday February 14, 2017.

Amgen’s Hyperparathyroidism Drug Approved by FDA
Amgen has received approval from the US Food and Drug Administration for Parsabiv (etelcalcetide) for treating secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

Parsabiv is a calcimimetic agent that can be delivered intravenously at the end a hemodialysis session. A calcimimetic mimics the action of calcium by activating calcium-sensing receptors on the parathyroid gland, according to Amgen.

Source: Amgen

EC OKs Lilly’s RA Drug
The European Commission (EC) has granted marketing authorization in Europe to Eli Lilly and Company and its partner, Incyte, a Wilmington, Delaware-based biopharmaceutical company, for Olumiant (baricitinib) 4 mg and 2 mg film-coated tablets, a drug for treating moderate-to-severe active rheumatoid arthritis (RA).

The indication is specifically for treating adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs. Olumiant may be used as a monotherapy or in combination with methotrexate.

As a result of the EC’s approval, Incyte becomes eligible to receive a milestone payment of $65 million from Lilly, which it expects to record in full in the first quarter of 2017. In December 2009, Lilly and Incyte entered into an exclusive worldwide license and collaboration agreement to develop and commercialize baricitinib, the active ingredient in Olumiant, and certain follow-on compounds for inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for treating rheumatoid arthritis in the US, European Union, and Japan in 2016.

Baricitinib is a once-daily oral, selective, and reversible Janus kinase-1 (JAK1) and JAK2 inhibitor. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for treating a range of inflammatory conditions, including rheumatoid arthritis, according to Lilly. Baricitinib is currently in clinical studies for inflammatory and autoimmune diseases. It is being studied in Phase II trials for atopic dermatitis and systemic lupus erythematosus. In addition, a Phase III trial for psoriatic arthritis is expected to be initiated in 2017.

Source: Eli Lilly and Company

FDA Updates Labeling for Lilly’s Diabetes Drug
The US Food and Drug Administration (FDA) has included changes to the approved product labeling for Eli Lilly and Company‘s Trulicity (dulaglutide), a glucagon-like peptide-1 receptor agonist approved for treating Type 2 diabetes. The label is now updated to include use in combination with basal insulin for treating adults with Type 2 diabetes. Trulicity is a key drug in Lilly’s diabetes franchise with $926 million in 2016 sales.

Trulicity was first approved by the FDA in September 2014 as a once-weekly injectable prescription medicine to improve blood sugar in adults with Type 2 diabetes, based in part on results from five Phase III studies of Trulicity used alone or in combination with other diabetes medications, including metformin, pioglitazone, glimepiride, and insulin lispro.

Source: Eli Lilly and Company

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