EC adopts recommendation keeping Esmya as last resort
Image by LaMography/Moni Lazar
The European Commission has adopted a recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to keep Hungarian pharmaceutical company Gedeon Richter's drug for uterine fibroids Esmya available for women who have no other treatment options, Richter said in a disclosure, according to a report by state news wire MTI.
Esmya may now only be used to treat uterine fibroids in premenopausal women "for whom surgical procedures...are not appropriate or have not worked", Richter said.
Last September, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) had recommended revoking authorizations for the sale of products containing 5-mg ulipristal acetate, the active ingredient in Esmya, after a benefit-risk analysis, because it can cause liver injury. In November, CHMP endorsed PRAC's assessment of the risk of liver injury, but said the benefits of 5-mg ulipristal acetate may outweigh the risks in women who have no other treatment options. It recommended making the drug available to treat premenopausal women who could not have surgery or for whom surgery had not worked.
The CHMP recommendation was forwarded to the European Commission for its decision and the use of Esmya suspended, as a precaution, pending the outcome of the EC's review.
Esmya was earlier among Richter's best-selling products until restrictions were placed on sales after the EMA concluded that the drug may have contributed to the development of some case of serious liver injury. In 2019, Richter booked HUF 29 billion in impairment losses on Esmya.
Hungary Gasoline Prices 3% Over Regional Avg
Hungary to Address Future of Cohesion Policy During EU Presi...
Cordia’s Marina City Project Begins
Budapest Airport Wins 'Best Airport in Eastern Europe' for 1...
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.
