Genzyme said today that its once-daily oral drug Aubagio for the treatment of adult patients with relapsing-remitting multiple sclerosis has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
Aubagio is approved to treat relapsing MS in the United States and Australia. There are nearly 630,000 people affected by MS in Europe, officials said.
However, the CHMP did not recommended that Aubagio receive a new active substance designation.
"We are very disappointed about the CHMP opinion regarding new active substance designation. We believe based on the product's characteristics and current data that Aubagio is a new active substance," said Genzyme CEO and President David Meeker in a statement. "Aubagio has been studied over 10 years in one of the largest and broadest clinical development programs of any MS therapy. This decision could have a detrimental impact on future scientific innovation in MS and other diseases. We are considering all options and planning to request a re-examination of the new active substance designation."
Additional marketing applications for Aubagio are under review by regulatory authorities around the world, officials said.
Meanwhile, Ariad Pharmaceuticals Inc. also announced today that the CHMP gave a positive opinion on the marketing authorization application for Iclusig, also known as ponatinib, for treating patients with specific forms of leukemia.
The CHMP granted Ariad accelerated assessment for its review of the Iclusig marketing authorization application last summer, officials said.
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