Biogen: Tecfidera MS Pill Was 'Unlikely' To Cause Patient Death

Is the 'holy mother' of all drug launches about to get deflated? For awhile, investors were concerned over a report that the new Tecfidera multiple sclerosis pill may have been linked to a patient death and Biogen Idec shares began sliding amid speculation that the drug may have the kind of side effect problem that could derail blockbuster sales estimates. Initially, there was talk that the patient died of dehydration, and Tecfidera can cause diarrhea and vomiting in some patients. But by the time the markets closed yesterday, the drugmaker was scrambling to dispel concerns by reaching out to investors, analysts and the media as quickly as possible. A spokeswoman told us that the patient, a 59-year-old woman, was treated with Tecfidera for nearly six weeks, but discontinued use due to gastrointesinal symptoms - nausea, vomiting and diarrhea. These subsequently abated, but she died two and a half weeks later from bilateral pneumonia. This occurs more frequently in MS patients. Moreover, the patient also had a history of irritable bowel disease and recurring infections, including bronchitis. “This is an important detail,” says the spokeswoman. The death “is not GI-related… Based on the circumstances and cause of death , a link to Tecfidera is unlikely." Just the same, Biogen (BIIB) is going to have continue with its analysis. “It’s all relatively new,” the spokeswoman acknowledges. “This is based on information we’ve been able to confirm. It will probably be...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs