The US Food and Drug Administration says it has approved 35 new medicines over the past year, and claims that it is getting drugs to patients faster than its counterparts around the world.
The agency notes that the figure is among the highest number of approvals in the past decade, surpassed only by 2009 (37). It notes that 24 of those occurred before any other country in the world and also before the European Union, "continuing a trend of the USA leading the world in first approval of new medicines".
Of the 35 approvals (for the period ended September 2011), the FDA noted that many of the drugs "are important advances for patients". These include two new treatments for hepatitis C - Merck & Co's Victrelis (boceprevir) and Vertex's rival Incivek (telaprevir) - a drug for late-stage prostate cancer - Johnson & Johnson’s Zytiga (abiraterone) - the first new treatment for Hodgkin's lymphoma in 30 years - Seattle Genetics’ Adcetris (brentuximab vedotin) - and the first lupus treatment in 50 years, GlaxoSmithKline and Human Genome Sciences' Benlysta (belimumab).
The FDA noted that 16 of the drugs were approved under priority review, ie in six months, and two-thirds were completed in a single review cycle. Three got the green light using accelerated approval, while thirty-four were approved on or before the review time targets under the Prescription Drug User Fee Act (PDUFA).
Before the PDUFA programme, "American patients waited for new drugs long after they were available elsewhere," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. She added that treatments are now made "rapidly available to patients in the USA, while maintaining our high standards for safety and efficacy".