Sepracor Wins EU Positive Opinion for Insomnia Drug MAA
US-based pharmaceutical company Sepracor has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending to grant a marketing authorization for Lunivia brand eszopiclone in the EU for the treatment of insomnia.
The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short term. Lunivia is marketed in the US under the brand name Lunesta.
Adrian Adams, president and CEO of Sepracor, said: “We are pleased with the Committee for Medicinal Products for Human Use’s decision to support approval of Lunivia in the EU, a decision that we feel reflects the regulatory agency’s satisfaction with the quality, safety and efficacy of the product in both the short and long-term treatment of insomnia.
“However, we are considering requesting a re-examination of the opinion relating to the exclusion of a new active substance designation that we feel would enable more favorable commercialization of the product.”
Sepracor entered into an agreement in September 2007 with GlaxoSmithKline for worldwide (excluding North America and Japan) commercialization of eszopiclone for the treatment of insomnia.