Teva has won its first approval for Azilect (rasagiline) in Israel both as initial monotherapy in patients with early Parkinson’s disease, and as an adjunct treatment in the moderate-to-advanced stage of the disease. The company is hoping to launch the drug in this market in March this year.
“We are extremely pleased to have received the first approval for the marketing of Azilect here in Israel where the product originated and was developed. With additional approvals anticipated in other countries during 2005, Azilect should become an important treatment option for patients suffering from Parkinson’s disease,” said Israel Makov, Teva’s president and chief executive.
Teva and partner Lundbeck secured the backing of the European advisory panel, the CHMP, in November last year, and expects to win final approval and launch the drug in the first half of this year [[19/11/04f]]. In the all-important US market, the product has received an approvable letter [[06/07/04b]], and Teva has since filed its written response with the country’s Food and Drug Administration, which has up to six months to complete its review [[08/11/04f]].