European advisory committee declines to recommend Avastin approval for deadly brain cancer
BASEL, Switzerland A medical advisory committee in Europe has declined to recommend approval for a Roche drug as a treatment for a deadly form of brain cancer, Roche announced Friday.
The Swiss drug maker said the Committee for Medicinal Products for Human Use, which is responsible for initial assessment of drugs filed for regulatory approval in Europe, did not recommend approval for the drug Avastin (bevacizumab) alone or combined with the chemotherapy drug irinotecan for treating relapsed or progressive glioblastoma. Glioblastoma, or GBM, is the most aggressive type of primary malignant brain cancer.
The committee, which made its decision based on results of a mid-stage clinical trial that Roche had submitted, cited the lack of a comparator arm that included patients who did not take Avastin.
“We are very disappointed with the CHMP opinion, which will result in a delay to patients receiving an important new treatment option,” Roche Pharmaceuticals Division CEO William Burns said in a statement. “We strongly believe that Avastin is a new treatment option for physicians within the [European Union] which would bring hope to GBM patients and their families as it is today in the U.S. and other countries.”
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.