By Arpita Dutt
2017 has been a pretty good year for pharma and biotech stocks where FDA decisions are concerned. The regulatory body has approved 40 novel drugs so far in 2017, easily surpassing last year’s total tally of 22.
There were quite a few landmark approvals this year including the approval of a couple of gene-based therapies for cancer – Novartis’s (NVS – Free Report) Kymriah for the treatment of certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (“ALL”) and Gilead Sciences’s (GILD – Free Report) Yescarta, a cell-based gene therapy for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. These therapies have the potential to change the way we look at cancer treatments.
Other key approvals this year include Lilly’s Verzenio (advanced or metastatic breast cancer), Gilead’s Vosevi (hepatitis C virus), Puma’s Nerlynx (to reduce the risk of breast cancer returning), J&J’s Tremfya (moderate-to-severe plaque psoriasis), Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Quite a few of these drugs have blockbuster potential.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of December.
Cardiovascular Outcomes Data to be Part of Amgen’s PCSK9 Inhibitor Label? Amgen (AMGN – Free Report) is looking to add cardiovascular outcomes data to the label of its PCSK9 inhibitor, Repatha. With the FDA granting priority review to the company’s regulatory application, a response should be out on December 2.
With cardiovascular disease being the leading cause of death around the world, the addition of this data to Repatha’s label could boost the product’s sales. Sales of PCSK9 inhibitors, which were once considered to be worth multi-billion dollars, are yet to ramp up significantly. Repatha sales in the first nine months of 2017 were $221 million.
Amgen continues to work with payers to improve patient access to Repatha. If the FDA allows the addition of the cardiovascular outcomes data to the label, the company will be in a position to promote Repatha’s ability to reduce the risk of cardiovascular events like heart attacks and strokes.