Breaking News

Teva, Active Biotech to Continue Nerventra Development

May 23, 2014

Despite CHMP opinion, companies will pursue multiple sclerosis indication

Teva Pharmaceutical and Active Biotech will continue development of Nerventra (laquinimod) following the Committee for Medicinal Products for Human Use (CHMP) opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.
Both companies remain committed to the clinical development program for multiple sclerosis (MS) and will evaluate the CHMP feedback to determine potential next steps. To confirm the benefits of the drug on disability progression, Teva is conducting the Phase III CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. Teva is also investigating the potential of Nerventra in progressive forms of MS.  
“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,” said Michael Hayden, Teva's president of Global R&D and chief scientific officer. “We believe Nerventra has a favorable risk-benefit profile and the potential to fulfill an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS.”

Related Contract Manufacturing:

blog comments powered by Disqus
  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments

  • The Role of Alliances in Modern Drug Development

    The Role of Alliances in Modern Drug Development

    Dr. Claire Madden-Smith, Senior Vice President, Juniper Pharma Services||September 8, 2016
    Combining expertise to get drug candidates through development

  • Limiting APIs in Manufacturing Effluent

    Limiting APIs in Manufacturing Effluent

    Joan Tell, Robert Drinane, Bruce Naumann, Jessica Vestel, and Gregory Gagliano, Merck & Co., Inc.||June 2, 2016
    An approach for setting limits on pharmaceuticals discharged in manufacturing effluent