Bloomberg the Company & Products

Bloomberg Anywhere Login

Bloomberg

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.

Company

Financial Products

Enterprise Products

Media

Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000

Communications

Industry Products

Media Services

Follow Us

Medicines Co.’s Drug Fails to Win FDA Panel Backing

Feb. 12 (Bloomberg) -- Medicines Co.’s experimental drug cangrelor failed to win the backing of U.S. advisers to prevent blood clots in patients undergoing a procedure to unblock heart arteries.

A Food and Drug Administration advisory panel voted 7-2 that cangrelor shouldn’t be approved. Panel members at the meeting in Silver Spring, Maryland, were concerned about the design of the clinical trial comparing the drug to an older anti-clotting medicine. Cangrelor also had higher bleeding rates than the older therapy.

Cangrelor may generate $400 million in sales if approved, Adnan Butt, an analyst at RBC Capital Markets, said in a note to clients on Feb. 7. Almost all of Medicines Co.’s $559 million in revenue in 2012 came from its anticoagulant Angiomax.

Medicines Co.’s shares were halted today because of the meeting. The FDA is expected to decide whether to clear cangrelor for sale by April 30 and doesn’t have to follow the panel’s recommendation,

Medicines Co. had announced it was shelving cangrelor in 2009 after earlier trials showed the therapy wasn’t more effective than other drugs. The Parsippany, New Jersey-based company said last year it found in follow-up studies the therapy significantly outperformed Plavix, a blood thinner from Sanofi and Bristol-Myers Squibb Co., that has lost patent protection and is now in generic forms.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.