Drugs

CDER Approvals Double to 46 Innovative Products

CDER innovative drug approvals sharply rebounded in 2017 — more than doubling the 22 products approved in 2016, which was a significant down year for approvals. In all, the Center approved 46 innovative NDA/BLAs last year. In contrast, there were just 22 approved in 2016 and 45 in 2015, according to approval reports.

Preliminary data released by CDER officials last month showed that the U.S. continues to lead the world in “first approvals” for innovative products (new molecular entities). The data showed that 2017 had a record number of orphan indications approved across all NDAs and BLAs, and new applications submitted increased across the board compared to five-year averages — 48 new molecular entities (NME) and original BLAs (14% increase), 106 non-NME NDAs (28% increase), and 231 efficacy supplements (43% increase).

2017 also saw continued efficiencies in first-cycle reviews, according to the officials. All of the NMEs/BLAs approved through early December met their user fee goal dates, and 88% of the drugs approved were approved in the first review cycle. And drug sponsors continue to favor FDA expedited development programs as follows:

More than two–thirds (70%) of the drugs in 2017 were approved under priority review
About four out of 10 (43%) of the drugs received a breakthrough therapy designation
Almost half (45%) of the drugs approved received a fast track designation

As for CDER goals in 2018, the officials said recruitment and hiring continue to be a priority. A year ago, there were 1,108 full-time equivalents working at CDER. They projected that by 12/31/2017 there would be 1,198 on board — a net 90 (8%) more employees over the past year. The officials expect to be implementing the new user fee agreements this year and activities related to the 21st Century Cures Act.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome