Two pharmaceutical companies, Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech, have just confirmed reports that the Committee for Medicinal Products for Human Use (CHMP) is not recommending NERVENTRA (laquinimod) for use in treating relapsing-remitting multiple sclerosis (RRMS) within the European Union (EU), according to a recent press release.
Despite CHMP’s disapproval of TEVA and Active BioTech’s primary product for MS, both companies remain determined to continue to develop the experimental therapy so that it can be approved and released onto the market. As a result, they will be looking into the reasons for the committee’s decisions, and will revise plans for approval from there.
Michael Hayden, the President of Global R&D and Chief Scientific Officer, noted that they were quite disappointed with the CHMP’s evaluation of NERVENTRA. Now they are eager to begin work with the EMA to make the drug available sooner to patients with MS in the EU. The companies believe their product has a positive risk vs. benefit ratio, and that it has significant potential to satisfy the still unmet and growing need for an MS treatment that preserves a patient’s brain volume and reduces the disease’s progression.
In order to back the drug’s demonstrated ability to slow MS progression, TEVA’s CONCERTO trials are currently underway, accounting for the most sizable trial for MS that uses disability progression as its chief endpoint. These trials will serve as the 3rd Phase III investigation for RRMS and aims to study the benefits of daily doses of 0.6mg and 1.2mg of NERVENTRA.
Furthermore, TEVA is currently exploring the possibility of using the drug to treat progressive subtypes of MS. The company is expecting to initiate the first series of trials for this purpose very soon.
In another news report on MS, Opexa Therapeutics in The Woodlands, Texas, was able to complete participant enrolment for their Phase Ilb “Abili-T” clinical study for Tcelna, indicated for Secondary Progressive Multiple Sclerosis. Click here to find out more.