European Medicines Agency panel recommends approval for Elonva
WHITEHOUSE STATION, N.J. A European medical advisory committee has recommended approval for a biotech drug made by Merck & Co. for women who have difficulty conceiving.
Merck announced that the Committee for Medicinal Products for Human Use, part of the European Medicines Agency and similar to the advisory committees of the U.S. Food and Drug Administration, recommended approval for Elonva (corifollitropin alfa), designed to stimulate follicle growth as part of controlled ovarian stimulation treatment in women participating in assisted reproductive technology programs.
“Elonva will reduce the burden of injections for women experiencing difficulty conceiving, and the positive opinion is an important step toward European approval,” Merck Research Labs SVP Mirjam Mol-Arts said in a statement. “Elonva demonstrates Merck’s commitment to providing effective patient-focused fertility treatments and extends the company’s leadership in this therapy area.”
Congress investigates rising drug prices
NEW YORK An article in The New York Times about rising drug prices has sparked an investigation by members of Congress, the newspaper reported Thursday.
Based on calculations by Wall Street analysts, IMS Health and AARP, the Times reported Sunday that while drug makers had promised to lower overall drug prices by $8 billion, wholesale prices of branded drugs had risen by 9%, to $10 billion. This happened despite a concurrent 1.3% contraction of the Consumer Price Index.
Now, Democratic Reps. Charles Rangel of New York, John Lewis of Georgia, Henry Waxman and Pete Stark of California and Florida Democratic Sen. Bill Nelson have asked the inspector general of the Department of Health and Human Services for “an immediate and thorough investigation into drug industry pricing and recent increases, and the extent to which these increases may affect the Medicare and Medicaid programs,” the Times reported.
The Pharmaceutical Research and Manufacturers of America, which represents the drug industry, criticized the Times’ article.
“Unfortunately, today’s New York Times only tells half a story, using selected statistics to make a flawed assumption that an increase in drug prices must somehow be tied to healthcare reform,” PhRMA SVP Ken Johnson said in a statement. “In truth, price increases are the natural result of market forces.”
Johnson said drug companies determined prices independently based on considerations such as patent expirations and research and development costs, noting that many of PhRMA’s member companies have experienced flat or negative revenue growth.
AstraZeneca seeks approval for Brilinta
WILMINGTON, Del. AstraZeneca has submitted an approval application to the Food and Drug Administration for an antiplatelet drug, the Anglo-Swedish drug maker announced Thursday.
The company said the drug, with the proposed brand name Brilinta (ticagrelor), reduces the risk of heart attacks and other cardiac events in patients with acute coronary syndrome.
The submission is based on results of a phase 3 trial comparing Brilinta with Plavix (clopidogrel), made by Bristol-Myers Squibb Co. and Sanofi-Aventis in patients also taking aspirin.