Mylan, Biocon, Lilly Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Mylan, Biocon, and Eli Lilly and Company.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 30, 2018 date to Tuesday June 5, 2018.

FDA OKs Mylan’s, Biocon’s Biosimilar of Amgen’s Cancer Drug Neulasta
The US Food and Drug Administration (FDA) has approved Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim), from Mylan and Biocon, a Bangalore, India-based pharmaceutical company, for treating neutropenia, or low white blood cell count, in patients treated with chemotherapy in certain types of cancer. Neulasta had 2017 global sales of $3.93 billion.

Fulphila is the second biosimilar from Mylan and Biocon’s joint biosimilar portfolio approved in the US. Mylan says it anticipates launching Fulphila in the coming weeks.

Source: Mylan

FDA OKs Lilly’s Cancer Drug Alimta in Combination with Merck & Co.’s Keytruda
The US Food and Drug Administration (FDA) has approved a new indication for Eli Lilly and Company’s cancer drug Alimta (pemetrexed for injection) in combination with carboplatin and Merck & Co.’s cancer drug Keytruda (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer.

Merck & Co. received accelerated approval for the combination of pembrolizumab with Alimta and carboplatin in May 2017.

Source: Eli Lilly and Company

FDA OKs, Lilly’s and Incyte’s Rheumatoid Arthritis Drug
The US Food and Drug Administration (FDA) has approved from, a 2-mg dose of Olumiant (baricitinib), a once-daily oral medication for treating moderately to severely active rheumatoid arthritis (RA) from Eli Lilly and Company and Incyte, a Wilmington, Delaware-headquartered biopharmaceutical company. The drug was approved for adults who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.

The companies had received a Complete Response Letter (CRL) from the FDA in April 2017 that sought additional clinical data to determine the most appropriate doses of the drug and to further characterize safety concerns across treatment arms. The companies were seeking approval for both a 4-mg and 2-mg dosing. The FDA has granted approval for only the 2-mg dose and is requiring a Boxed Warning on the label for the risk of serious infections, malignancies, and thrombosis. As part of the approval, the companies have agreed to conduct a randomized controlled clinical trial to evaluate the long-term safety of baricitinib in patients with rheumatoid arthritis. The drug was approved in the European Union in 4-mg and 2-mg dose tablets in February 2017.

Lilly says it will launch Olumiant in the US by the end of the second quarter of 2018. Incyte is eligible to receive a $100 million milestone payment from Lilly as a result of the approval, which Incyte expects to recognize in the second quarter of 2018.

Source: Eli Lilly and Company and Incyte

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