Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE:TEVA) has revealed that its Marketing Authorization Application (MAA) for Fremanezumab has been accepted by the European Medicines Agency (EMA).
Fremanezuman is an anti-calcitonin gene-related peptide (CGRP) antibody that Teva developed for preventing episodic and chronic migraine in adult patients. The drug is administered through monthly or quarterly injections that should be handled by healthcare professionals although patients can also inject themselves. The same treatment received FDA acceptance for review in December last year.
“The successful filing of the MAA for fremanezumab with the EMA builds on the momentum of the global fremanezumab program, following acceptance of the Biologics License Application with the US Food and Drug Administration,” stated Ernesto Aycardi, the head of the Data Sciences and Biometrics & Clinical Pharmacology division as well as clinical trial execution at Teva.
Aycardi also described the EMA’s acceptance of the MAA as a key step towards advanced treatments for patients suffering from migraine. This is especially considering that there are currently very limited preventive treatment options that focus on the underlying biological causes of migraines. The recent approval, as well as Teva’s ongoing development for the migraine treatment, are proof of the company’s commitment towards providing a strong solution for patients that suffer from these conditions.
Teva submitted the application backed by data that it collected from the HALO clinical trial which involved more than 2,000 participating patients who suffered from chronic migraine (CM) and episodic migraine (EM). The clinical trial evaluated monthly and quarterly doses and the results demonstrated appealing results which were able to meet all the endpoints. Some of the side effects of the treatment include pain in the injected area, erythema and induration.
About 875 patients were enrolled into the EM study with some of them in the placebo. The CM study had 1,130 participating patients which is more than those in the EM study. Each of the trials had a 28-day baseline run-in period and each evaluation lasted about 12 weeks.
Teva stock closed the latest trading session on Monday at $19.74 after tanking by 4.04 percent compared to the value of the stock during the previous close.