FDA approved 35 new drugs in 2011 financial year

The US Food and Drug Administration has approved 35 new medicines in the past 12 months. This is among the highest number of approvals in the past decade, surpassed only by 2009, in which 37 were approved.

Many of the drugs are groundbreaking and offer advances in treatments for hepatitis C; late-stage prostate cancer; Hodgkin’s lymphoma and lupus.

In a report released today (3 November), FY 2011 Innovative Drug Approvals, the FDA said it had accelerated the review and approval of these drugs by using ‘expedited approval’ pathways and by streamlining clinical trial requirements to permit smaller, shorter, or fewer studies wherever possible.

With the help of these tools and the resources collected under the Prescription Drug User Fee Act (PDUFA), the FDA was able to review these 35 new drugs quickly and efficiently.

Twenty-four of the 35 approvals occurred in the US before any other country in the world and also before the European Union.

‘Thirty-five major drug approvals in one year represents 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,’ said Margaret Hamburg, Commissioner of Food and Drugs.

Among the new drugs approved in FY 2011, a number are notable for their advances in patient care and for the efficiency with which they were approved:

• Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalised medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
• Seven of the new medicines provide major advances in cancer treatment;
• Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
• Ten are for rare or ‘orphan’ diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
• Almost half (16) were approved under ‘priority review’, in which the FDA has a six-month goal to complete its review for safety and effectiveness;
• Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
• Three were approved using ‘accelerated approval’, including Corifact, the first treatment approved for a rare blood clotting disorder; and
• Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.

Congress established the PDUFA in 1992 to ensure that the FDA had the resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on 30 September 2012.

‘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.

Hamburg said the FDA is also committed to supporting innovation in the biopharmaceutical industry. She has launched the Innovation Initiative, identifying additional steps the agency can take to reduce the length and cost of drug development and increase its predictability. For example, the FDA is working on initiatives to make clinical trials smaller, more efficient, and less uncertain, and to enhance use of pharmacogenomics and qualified biomarkers.

The agency is also continuing to support the progress of personalised medicine, and is allocating more resources to expediting orphan drug development. With this effort, FDA can help speed the availability of new products, identify products that might be safer or more effective than existing therapies, and give doctors and scientists better information about how drugs work.

Last month 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies.