Dallas, Texas 12/13/2013 (FINANCIALSTRENDS) – Danish pharmaceutical firm ALK declared that it had bagged unanimous backing from a USFDA advisory group for oral medicine Gratsek. The medicine, devised to take care of glass pollen allergic reactions, is one developed as part of ALK’s strategic affiliation with Merck & Co., Inc. (NYSE:MRK), a marriage which will offer the latter authorization to market and market the product in North American zones.
The FDA stated that the available facts revealed Gratsek’s effectiveness and protection among sufferers aged 5 to 65 years, but suggested further researches connected to its utilization among kids aged 11 years and below.
“ALK greets the FDA Advisory Committee’s conclusion that shows another vital step in this direction bringing this pioneering new cure to U.S. sufferers,” ALK chief executive officer Jens Bager stated in a declaration.
The FDA will appraise the company’s Biologic License Application for Gratsek, taking the advisory group’s opinion into thought, and the medicine’s authorization could be permitted as early as the first half of the coming year.
Merck & Co., Inc. (NYSE:MRK) Alzheimer’s medicine enters Phase III
Merck & Co., Inc. (NYSE:MRK) has reported promising development for its tentative Alzheimer’s drug MK-8931 after an optimistic safety appraisal.
A data monitoring group has considered interim security data from the stage II/III EPOCH research that comprised a safety cohort of 200 sufferers with mild to moderate Alzheimer’s handled with the medicine for at least 3 months. Based upon the DMC’s suggestions, Merck will carry on enrollment of the EPOCH research and will start dosing in a novel Phase III research (named APECS) assessing MK-8931 in sufferers with amnestic mild cognitive impairment because of Alzheimer’s.
The EPOCH experiment is now expected to enroll up to 1,960 sufferers, whilst Merck & Co., Inc. (NYSE:MRK) is making plans to take on 1,500 partakers for APECS.