FDA places Amicus's Pompe trial on hold due to safety concerns
This article was originally published in Scrip
Executive Summary
Amicus Therapeutics has suspended enrolment in its Phase II trial of its orphan drug candidate AT2220 (1-deoxynojirimycin HCl) for the treatment of Pompe disease, following a verbal request by the FDA after two patients reported serious adverse events which were probably related to treatment with the drug. The US agency has put the trial on clinical hold.
You may also be interested in...
P&G to co-promote Somaxon's Silenor in the US
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US.
GSK's shingles vaccine begins Phase III studies
GlaxoSmithKline has begun the Phase III clinical trials programme for its adjuvanted vaccine candidate (GSK1437173A) against herpes zoster for the prevention of shingles.
Optimer's fidaxomicin filing accepted in EU
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI.