7 February 2018 - - The European Medicines Agency (EMA) has accepted Petach Tikva, Israel-based generic and specialty medicines company Teva Pharmaceutical Industries Ltd.'s (NYSE and TASE: TEVA) marketing authorization application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide antibody for the prevention of episodic and chronic migraine in adults, the company said.
Fremanezumab is a quarterly or monthly injection that may be administered by a healthcare professional, or self-administered by the patient.
The MAA includes data from the HALO clinical trial program, which enrolled more than 2,000 patients with episodic migraine and chronic migraine, evaluating both quarterly and monthly dosing regimens, in which fremanezumab achieved statistically significant results across all trial endpoints.
The most common adverse events reported in clinical trials include injection site pain, induration, and erythema.
Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP ligand, a well-validated target in migraine. It is also being investigated for the prevention of chronic and episodic cluster headache, and Teva also recently initiated a fremanezumab Phase II clinical program for the treatment of post-traumatic headache disorder.
Teva delivers high-quality, patient-centric healthcare solutions company, and generic and specialty medicines producer.
It leverages its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area.
In specialty medicines, the company has an innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products.