2017 Winter Newsletter- 2016 New Drug Approvals

2016: The Decline of New Drug Approvals and Increase in Expedited Reviews

According to the FDA, only 22 novel new drugs were approved in 2016.  This is a 50% decrease from 2015.  Novel drugs, or new molecular entities, are defined by the FDA as “products containing active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product.”  After two record-breaking years of new drug approvals, 2016 is a bit of a letdown for prescribers and patients hoping for new, innovative therapies.  Last year was the lowest number of novel new drug approvals since 21 drugs were approved in 2010.  The chart below shows the trend in the number of new drug approvals for the last six years.

Novel Drug Approvals

Similar to 2015, the largest number of products approved in 2016 were indicated to treat different types of cancers.  For example, Lartruvo was approved to treat soft tissue sarcoma; Rubraca treats ovarian cancer.  Venclexta is indicated for chronic lymphocytic leukemia, and Tecentriq treats bladder cancer.

All of these oncology agents were breakthrough therapies that received FDA priority reviews and accelerated approvals due to the positive implications for patients.  When reviewing all 2016 approvals, priority review is the new norm vs. the exception, as 68% of all 2016 approvals had a priority review.  This could also indicate that few manufacturers are pursuing follow-on drugs in therapeutic categories that already have multiple available drugs.

Based on 2015 and 2016 approvals, special distinctions and expedited approvals from the FDA appear to be becoming more common.  The FDA defines these distinctions as:

First-in-Class: Drugs having mechanisms of action different from those of existing therapies (36% of 2016 approvals)

Drugs for Rare Diseases: Drugs approved to treat rare or “orphan” diseases affecting 200,000 Americans or less (41% of 2016 approvals)

Fast Track: Drugs having the potential to address unmet medical needs (36% of 2016 approvals)

Breakthrough: Drugs with preliminary clinical evidence demonstrating that the drug may result in substantial improvement on at least one clinically significant endpoint versus other available therapies (32% of 2016 approvals)

Priority Review: Drugs are reviewed within six months instead of the standard ten months if the drug could potentially provide a significant advance in medical care (68% of 2016 approvals)

Accelerated Approval: Approval is based on a “surrogate endpoint”, such as a lab value or clinical measure, that the FDA considers reasonably likely to predict the drug’s clinical benefit and allows for earlier approval for drugs treating serious or life threatening illness that offer a benefit over current treatments (27% of 2016 approvals)

The same drug may fall into multiple categories.  The chart below summarizes the 2016 novel drug approvals with special distinctions and/or expedited approvals, as noted by the FDA.

2016 also saw a number of first-time generic launches.  The biggest generic launch of the year was generic rosuvastatin (Crestor).  Other notable brands losing patent protection and becoming availability generically included Benicar (olmesartan), Tamiflu (oseltamivir), and Zetia (ezetimibe).  There were a few notable generic specialty launches in 2016 including imatinib (Gleevec) and valganciclovir (Valcyte), reducing the cost for patients taking these medications.  Although generics are now more common in the specialty space, brand drugs still dominate specialty pharmacy, and PHSI estimates that only 6 of the 22 new drug approvals are traditional retail pharmacy products.

As 2017 unfolds, look for more of the 2016 approvals to become commercially available and appear on drug formularies.  Due to high costs and limited patient population sizes, we anticipate many of these agents being placed on specialty drug tiers due to the high rate of 2016 approvals for drugs treating rare disease states.  PHSI expects this trend to continue in 2017 and will report on the new approvals and their effects on the industry.

 

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