European Medicines Agency forms positive opinion on PregLem drug
Hungarian drugmaker Gedeon Richter on Friday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion for a trademarked drug for the treatment of uterine fibroids made by its wholly-owned unit PregLem.
Richter said PregLem was expected to receive a marketing authorisation for the drug, called Esmya, valid for all European Union member states in early 2012, subject to approval by the European Commission.
"Esmya is the first new treatment to be launched for that condition in more than 20 years. The positive CHMP opinion confirms Esmya therapeutic potential and is an important milestone towards making Esmya available for addressing the unmet medical needs of women with uterine fibroids", said PregLem CEO Dr. Ernest Loumaye, Chief Executive Officer of PregLem.
SUPPORT THE BUDAPEST BUSINESS JOURNAL
Producing journalism that is worthy of the name is a costly business. For 27 years, the publishers, editors and reporters of the Budapest Business Journal have striven to bring you business news that works, information that you can trust, that is factual, accurate and presented without fear or favor.
Newspaper organizations across the globe have struggled to find a business model that allows them to continue to excel, without compromising their ability to perform. Most recently, some have experimented with the idea of involving their most important stakeholders, their readers.
We would like to offer that same opportunity to our readers. We would like to invite you to help us deliver the quality business journalism you require. Hit our Support the BBJ button and you can choose the how much and how often you send us your contributions.