We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
FDA Approvals Surge in 2017: Here's a Look at the Numbers
Read MoreHide Full Article
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 - Free Report) Kymriah and Gilead Sciences’s (GILD - Free Report) Yescarta. These therapies have the potential to change the way we look at cancer treatments.
Other key approvals included Lilly’s (LLY - Free Report) 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 - Free Report) /Sanofi’s Kevzara (rheumatoid arthritis), Roche’s (RHHBY - Free Report) 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 - Free Report) investigational migraine drug, Aimovig (target action date of May 17, 2018), Dova Pharmaceuticals’s avatrombopag, and GW Pharmaceuticals’s 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.
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Image: Bigstock
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 - Free Report) Kymriah and Gilead Sciences’s (GILD - Free Report) Yescarta. These therapies have the potential to change the way we look at cancer treatments.
Other key approvals included Lilly’s (LLY - Free Report) 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 - Free Report) /Sanofi’s Kevzara (rheumatoid arthritis), Roche’s (RHHBY - Free Report) 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 - Free Report) investigational migraine drug, Aimovig (target action date of May 17, 2018), Dova Pharmaceuticals’s avatrombopag, and GW Pharmaceuticals’s 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.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Click here for Zacks' private trades >>