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FDA Approvals Surge in 2017: Here’s a Look at the Numbers


2017 turned out to be a notable year for the pharma and biotech industry with the FDA giving its nod to 46 novel drugs as well as several biological license applications (“BLA”) including for path-breaking cancer treatments like Kymriah and Yescarta. This number compares favorably not only to 2016 when just 22 novel drugs were approved, but to earlier years as well. A look at the chart below shows that the highest number of approvals recorded since 1993 was in 1996 when 53 novel drugs were approved.

According to the FDA's Center for Drug Evaluation and Research (“CDER”), a higher number of new applications were submitted in 2017 compared to five year averages. As of Nov 30, 2017, all regulatory applications that were approved in 2017 met their PDUFA goal dates with quite a few approvals coming ahead of the FDA action date. About 88% of these drugs were approved in the first review cycle with 70% being approved under priority review status. As of Nov 30, 2017, the approval action rate was 82%.

Many of the drugs approved in 2017 had also gained Breakthrough Therapy designation – while 17 breakthrough therapies were approved last year (as of Nov 30, 2017), since inception, 192 Breakthrough Therapy designations have been granted by the CDER out of a total of 529 requests (as of Nov 30, 2017). A major part of the Breakthrough Therapy requests are for cancer drugs followed by hematology and antiviral.

Landmark decisions last year include the approval of a couple of gene-based therapies for cancer – Novartis’s NVS Kymriah and Gilead Sciences’s GILD Yescarta. These therapies have the potential to change the way we look at cancer treatments.

Other key approvals included Lilly’s LLY 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 REGN/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s RHHBY 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. Many of these drugs have blockbuster potential.

What’s in Store for 2018?

The FDA intends to continue working on the recruitment and hiring of new drugs program staff. The agency will also work on the continued implementation of new PDUFA VI and BsUFA II agreements, other aspects of the FDA Reauthorization Act of 2017 (“FDARA”) and the 21st Century Cures Act. The 21st Century Cures Act is expected to encourage more innovation in the sector and, maybe, a surge in new drug approvals.

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. Some of the key drugs currently under FDA review with decisions expected in the coming months include Amgen’s AMGN investigational migraine drug, Aimovig (target action date of May 17, 2018), Dova Pharmaceuticals’s avatrombopag, and GW Pharmaceuticals’s GWPH Epidiolex (cannabidiol or CBD), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (“LGS”) and Dravet syndrome. Epidiolex is currently under priority review for these two rare and difficult to treat conditions of childhood-onset epilepsy with a response from the FDA expected on Jun 27, 2018. Dova’s avatrombopag is also under priority review for the treatment of thrombocytopenia in patients with chronic liver disease (“CLD”) who are scheduled to undergo a procedure – a response from the regulatory body is expected on May 21, 2018.

Amgen is a Zacks Rank #3 (Hold) stock – you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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