FDA extends review time for prasugrel to end of September
TOKYO & INDIANAPOLIS The Food and Drug Administration has extended the review period for Eli Lilly’s and Daiichi Sankyo’s jointly developed drug anti-platelet prasugrel, the companies said Tuesday in a joint statement.
The FDA gave the companies’ application priority review in February, and the three-month extension will give it more time to complete its review, with a new action date of Sept. 26.
The companies intend for prasugrel to treat patients with acute coronary syndromes being managed with percutaneous coronary intervention, a procedure that opens arteries.
They also announced that a phase III study called TRILOGY ACS to compare the effects of prasugrel to clopidogrel bisulfate in patients with acute coronary syndromes.
“The initiation of the TRILOGY ACS trial demonstrates our continued commitment to investigate prasugrel as a potential therapy for ACS patients who are medically managed,” said John Alexander, Daiichi Sankyo’s global head of research and development.
Clopidogrel bisulfate, marketed by Bristol-Myers Squibb and Sanofi Aventis under the brand name Plavix, had sales of $4.76 billion in 2007, according to Bristol-Myers Squibb financial data.
FDA requests delay on Merck application for cholesterol drugs
BOSTON The Food and Drug Administration has recommended that Merck wait until it finishes clinical trials of the cholesterol drugs MK-0524A and MK-0524B before re-filing a marketing application for them, Merck announced Friday.
The FDA rejected Merck’s application for the two drugs in April, and the FDA has advised that it should wait until it receives results from the clinical trial before re-filing.
MK-0524A is a combination of the drug Cordaptive and niacin; MK-0524B combines those ingredients with Zocor. Merck has said it does not plan to seek approval for MK-0524B until it completes the application for MK-0524A.
Adheris’ Glaser dies at 53
BURLINGTON, Mass. Matthew Glaser, 53, senior vice president of Professional Services for Adheris, passed away from cancer this past Saturday.
Glaser was a respected leader in the retail pharmacy industry who spent over 30 years working in community, chain, hospital and institutional pharmacy settings. Since 1996, he had dedicated his experience and skills to growing Adheris from a start-up to a leading provider of pharmacy-based patient education and adherence programs. At Adheris, he worked with chain and independent pharmacies, ensuring the delivery of appropriate compliance and adherence programs to their patients.
Prior to his tenure at Adheris, Glaser served as vice president of Pharmacy and Professional Affairs for Brooks Pharmacy, and as assistant vice president of Professional Services and vice president of Managed Care at Hook-SupeRx. Earlier in his career, he spent several years serving in various management positions at CVS.
Glaser held a Bachelor of Science degree in Pharmacy from Northeastern University.
Glaser is survived by his four children; his mother and several siblings and nieces and nephews. Memorial contributions may be made in his memory to the Matthew P. Glaser Memorial Scholarship Fund at the Massachusetts College of Pharmacy, Office of Advancement at 179 Longwood Ave., Boston, MA 02115.