U.S. approvals of new drugs hit a seven-year high last year as pharmaceutical companies responded to regulators’ demands forbetter safety data and avoided last- minute requests for more information.
The Food and Drug Administration cleared 30 new treatments in 2011 compared with 21 the year before, a Bloomberg review of agency records shows. Johnson & Johnson and GlaxoSmithkline Plc each had three products approved after no company had more than one medicine cleared in 2010.
More frequent approvals may help drugmakers overcome a rash of patent expirations. At least 21 medicines will lose a combined $11.5 billion in revenue as a result of patent expirations in 2012, including Paris-based Sanofi (SAN) and Bristol- Myers Squibb Co. (BMY)’s anti-clotting treatment Plavix, projected to see $4.5 billion in lost sales, according to Bloomberg Industries. Drugmakers will generate more than $4 billion in 2012 from products that were introduced in 2010 and 2011.
Yervoy, Xarelto
Compounds approved in 2011 included New York-based Bristol’s Yervoy, the first drug cleared to prolong the lives of people with advanced skin cancer that uses patients’ immune systems to attack tumors, and New Brunswick, New Jersey-based J&J’s Xarelto, the second in a new class of anti-clotting therapies for people with irregular heartbeats.
The agency also cleared Benlysta, developed by London-based Glaxo and Rockville, Maryland-based Human Genome Sciences Inc. (HGSI) The compound is the first treatment for lupus, a debilitating autoimmune disorder, in 50 years.
New York-based Pfizer Inc. (PFE) leads drugmakers with 85 products in development, followed by Basel, Switzerland-based Roche AG (ROG) with 83 and Sanofi with 79.