Teva Pharmaceutical Industries and Active Biotech announced in a press release that they are committed to developing Nerventra (laquinimod) despite the Committee for Medicinal Products for Human Use’s (CHMP) refusal to approve it in the European Union (EU). The announcement came after CHMP reaffirmed its January decision to recommend against approval. The immunomodulator treatment is for relapsing-remitting multiple sclerosis (RRMS). The two companies intend to review the decision and determine the next steps.
Michael Hayden, President of Global R&D and CSO at Teva said, “We are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to multiple sclerosis patients in the EU.”
CHMP issued its decision on January 23, 2014 and Teva asked the agency to reconsider. CHMP recently confirmed its opinion and announced it via press release. Initially, CHMP stated that the way the agent works in the body is unclear. Since animal studies showed an increased risk of cancer, cancer risks in humans could not be excluded. Animal studies also showed that the drug could potentially harm an unborn child and that these risks could be applicable to humans. The agency found that Teva’s proposals to prevent pregnancies in women taking the drug were insufficient.
Upon re-examination, CHMP accepted opinions from experts in neurology. The experts said that if a clear clinical benefit was demonstrated, the cancer risks in animal studies were acceptable. They said, however, that a pregnancy prevention plan was critical. Due to the modest clinical benefit, CHMP decided that the benefits of Nerventra did not outweigh the risks.
Nerventra is an oral CNS-active immunomodulator, demonstrating neuroprotective and anti-inflammatory properties. Phase III clinical studies included ALLEGRO and BRAVO. The Phase III CONCERTO trial is underway, evaluating two doses (0.6mg and 1.2mg) for up to 24 months in 2,100 participants. The trial evaluates disability progression. The safety profile of Nerventra includes reactions, such as liver enzyme elevations, hematological changes, and elevation of CRP or fibrinogen levels. Teva is investigating Nerventra in other forms of MS and other neurodegenerative diseases, including Huntington’s disease.