• linkedin
  • Increase Font
  • Sharebar

    Why 2016 drug approvals fell

    While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.

    As of December 9, 2016, FDA approved 19 new therapies, compared to a significant 45 new drugs in 2015.

    Related: FDA approves expansion of Avastin in ovarian cancer

    However, the latest data from FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (CDER) also does not include existing drugs that were approved for new indications. For example, bevacizumab (Avastin, Genentech), which treats a variety of cancer types, was recently received the expanded indication for certain types of ovarian cancer.

    In addition, five new drugs that had been scheduled for approval in 2016 received early FDA approval at the end of 2015, John Jenkins, director of the Office of New Drugs, said at a recent conference, according to Reuters.

    Jenkins also that pharmaceutical manufacturers filed fewer new drug applications in 2016 and the agency rejected or delayed more applications in 2016 than in 2014 and 2015.

    Related: US drug spending predicted to drop

    Some of the delayed drugs, such as Ocrevus, a multiple sclerosis drug from Roche and sarilumab for rheumatoid arthritis from Sanofi and Regeneron, could still win approval in 2017.

    Meanwhile, novel drug approvals in 2016 were approved quickly. Thirty-seven percent of the novel drug approvals received fast-track designation, 37% are first in their class and 37% of the new drugs are for rare diseases. And 95% of the novel drugs approved in 2016 were approved in the first review cycle.

    Around two-thirds (68%) of novel drug approvals in 2016 were approved under priority review and 32% received breakthrough therapy designation. 

    Read more: FDA approves 2 injectable diabetes drugs

    Christine Blank
    Contributing Editor Christine Blank is a freelance writer based in Florida.

    1 Comment

    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • [email protected]
      I was diagnosed of Parkinson disease 2 years ago at age 63. Symptoms were tremor in right leg, loss of handwriting ability, and soft voice. I also have difficulty rising from a seated position and have balance issues. I started out taking only Azilect, then Mirapex, and last 2 month Sinemet. Several months ago I started falling frequently, hence the reason for Sinemet.My first son was in search of permanent cure because he spent a lot of money on my medication,so he check online and saw good testimonies about Parkinson disease cured with the help of herbal medicine purchased from perfecthealthherbalmedicinehome,so we decided to give it a try,we contacted perfecthealth through email perfecthealthherbalmedicine @ gmail .com and purchased the herbal medicine for Parkinson disease,we received the herbal medicine at our door step after two days of purchase ,the shipping was so fast.i used the herbal medicine for a month and 2 weeks,all my symptoms disappears,and my doctor confirmed am Parkinson disease free now ,i promised to tell the whole world about perfecthealthherbalmedicinehome.please contact perfecthealth to get your own cure , website :www perfecthealthherbal . weebly com.