Closer and more frequent communications with the U.S. Food and Drug Administration (FDA) are likely the main factors leading to a shorter approval time for breakthrough drug therapies, according to Fitch Ratings. Breakthrough therapy approvals more than tripled in 2014 versus 2013.
The FDA had approved 10 breakthrough therapies through Nov. 28 of last year compared to just three approvals during the entire year prior. Five out of 10 approvals in 2014 were for drugs that treat various cancers. No breakthrough therapies were approved in 2012, as the therapy designation was enacted in July of that year.
Two breakthrough therapies in particular are attracting collaborators: Keytruda (Merck & Co.) and Opdivo (Bristol-Myers/Ono) are increasingly being studied in combination with other drugs to treat various cancers.
The number of fast track designations through September 2014 (67) were above those of 2013 (53), indicating a higher level of future FDA approvals. The fast track therapy designation is similar to that of the breakthrough therapy, although the intensity of the FDA’s involvement in expediting the approval process is somewhat less for fast track programs.
NME approvals were also up during 2014. The FDA cleared 36 novel medicines for U.S. marketing during 2014 compared to 27 in 2013. Interestingly, 11 biologics were approved in 2014 compared to only three in 2013. We continue to expect biologics to play an increasing role in drug development.
Additional information is available on www.fitchratings.com.
