The FDA issued a report Thursday stating that the agency approved 35 new drugs in the 12 months ending September 30, marking the second highest number of approvals in the past decade, surpassed only by the 37 authorised in 2009. The approval rate is “a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients” FDA Commissioner Margaret Hamburg remarked.
The regulator attributed the authorisations to an expedited approval process, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act. The report comes as US Congress debates a renewal of the user-fee system already agreed upon by the FDA and the pharmaceutical industry, which would see a 6-percent fee increase through fiscal 2017. Under the deal, which Congress must approve by the end of September next year, drugmakers would pay $712.8 million in fees in fiscal 2013.
Janet Woodcock, director of the FDA’s center for drug evaluation and research, remarked that the regulator didn’t experience “a huge uptick” in the number of marketing applications in the 12-month period, but suggested that in previous years, many filings were for drugs that made moderate advances. “This year we’re just seeing a lot of innovation,” Woodcock commented. According to the FDA, almost half of the compounds cleared were considered “significant therapeutic advances over existing therapies” and 10 were for rare or orphan diseases.
The FDA noted that the report also demonstrated faster approval times in the US compared to other regulatory bodies. Specifically, 24 of the 35 approvals occurred in the US before any other country in the world and before the EU. Further, Richard Pazdur, leader of the office of oncology drug products within the center for drug evaluation and research, said approvals may accelerate as part of a September reorganisation of his office that focuses drug evaluation teams on afflicted body parts instead of the treatment’s composition.
Of the medications approved in the 12-month period, the FDA indicated that almost half were cleared under its priority review programme and three were authorised via the agency’s accelerated approval process. In addition, 34 of the 35 drugs were approved on or before review time targets and two-thirds were completed in a single review cycle. In terms of disease areas, the agency noted that seven of the new therapies provided “major advances in cancer treatment,” including Johnson & Johnson’s Zytiga (abiraterone) for metastatic prostate cancer and Roche and Daiichi Sankyo’s Zelboraf (vemurafenib) for metastatic melanoma. In addition, the regulator approved Seattle Genetics’ Adcetris (brentuximab vedotin), marking the first new drug for Hodgkin’s lymphoma in 30 years, and GlaxoSmithKline and Human Genome Sciences’ Benlysta (belimumab), which represents the first lupus treatment to garner approval in more than 55 years.
