By ANNA EDNEY
U.S. approvals of new drugs hit a seven-year high last year as pharmaceutical companies responded to regulators’
demands for better 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 (JNJ) and GlaxoSmithkline Plc (GSK) 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.
“I think people have realized that FDA has gotten more difficult and they’re improving what they turn in,” said Yaron Werber, an analyst with Citigroup Inc. in New York, in a telephone interview.
Bloomberg tracked approvals from an FDA database of “new molecular entities” that excludes blood products and new vaccines. The 30 drugs cleared last year were the most since 36 were cleared in 2004.
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.
The novel design of the drugs give the agency more flexibility evaluating them, said Janet Woodcock, the FDA’s director of drug evaluation.
“There’s a whole range of things that are novel,” Woodcock said. “That’s what we hope to keep seeing going forward.”
Congress expanded the FDA’s oversight powers in 2007 after the agency was slow to react to heart risks associated with Whitehouse Station, New Jersey-based Merck & Co. (MRK)’ s painkiller Vioxx and Glaxo’s diabetes pill Avandia. The FDA has since raised standards for safety and efficacy data required from companies, Werber said.
Companies meeting the criteria “are starting to see the fruits of their labor” after years of spending heavily on product research and development with little reward, said Michael Meyers, chief executive officer of Arcoda Capital Management in New York, in a telephone interview.
“I think the companies are being a lot more selective around where do they invest their own resources and where can they make the most impact,” Paul Huckle, Glaxo’s chief regulatory officer, said by telephone.
The FDA also is holding advance consultation with companies on what data should be included in drug applications to avoid having to make last-minute requests for more information on how a compound works, said Les Funtleyder, a portfolio manager with the Miller Tabak & Co. in New York, in a telephone interview.
Fewer Data Requests
Pharmaceutical companies filed 29 novel drug applications with FDA last year as of Nov. 30, compared with 22 in 2010, according to John Jenkins, the agency’s director of new medicines. Nineteen of the 30 therapies approved in 2011 were cleared without requests for more data, said Sandy Walsh, an agency spokeswoman, in an e-mail. In contrast, regulators approved about half of the 21 treatments in 2010 on the first try.
The pace of approvals this year may be influenced by the pace of Congressional efforts to renew the system that allows pharmaceutical companies to pay user fees for product evaluations. The drug industry and the FDA struck a deal last year to extend reviews two months in exchange for additional discussions while a medicine is being tested. Congress must pass the deal by Oct. 1, when the current user-fee system expires.
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, Meyers said.