US Food and Drug Administration staff has said Sanofi SA (ADR) (NYSE:SNY)’s drug Lemtrada, which is develop for treatment of multiple sclerosis, may not provide sufficient benefit to patients to overshadow possibilities of cancer. So these concerns may affect the drug success.
The potentially fatal and serious safety issues related to the drug may increase the risk of thyroid and autoimmune diseases, may hurdle the approval of the drug but the significant clinical benefit if emerged may increase the possibility of approval, revealed today by staff members of Food and Drug Administration. The regulator officials are also inquiring whether the drug maker conducted satisfactory trials to verify the yearly infusion works.
Zurich based analyst firm Kepler Cheuvreux analyst Fabian Wenner has revealed, it is similar to a death sentence, it is not is expected by everyone, this is a matter related to safety. It emerged to be a additional fundamental issue.
Earlier in 2013, Lemtrada was approved in Europe; however its approval in US is still pending. As Sanofi, a Paris-based firm takeover Genzyme Corp. for $20 billion in 2011, and at that time Lemtrada was in the middle of its development, and according to deal if Lemtrada approve in US than its shareholder will contingent price rights stand to get a cash payments. Bayer AG (BAYN) will also get its share in Lemtrada as it aim to co-promote the drug, but it payments will be based on sales of the drug.
On November 13 an advisory panel from regulatory authority will talk about the recommendation of the drug’s approval. The regulator is likely to make a decision whether to approve the medicine for clinical treating for MS patients till the end of 2013.
The drug maker has also filed its trial report that indicated Lemtrada had numerous advantages, as the company desire not to hide any material related to the trial, as to revealed to regulators that the therapy was working or not. Sanofi SA (ADR) (NYSE:SNY) share boosted 0.50% to $52.45 in last trading session.