Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Biogen receives CHMP backing for Spinraza in spinal muscular atrophy

Biogen receives CHMP backing for Spinraza in spinal muscular atrophy

26th April 2017

Biogen has announced that its drug Spinraza has been recommended for European regulatory approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has adopted a positive opinion recommending marketing authorisation for Spinraza as a treatment for spinal muscular atrophy (SMA) under an accelerated assessment programme.

This regulatory mechanism is designed to facilitate earlier access to patients for medicines that fulfil unmet medical needs, with Biogen's drug being the first treatment for SMA to be recommended by the CHMP for approval in the European Union.

Data from two pivotal controlled studies, ENDEAR and CHERISH, both demonstrated the clinically meaningful efficacy and favourable safety profile of this new drug.

Dr Michael Ehlers, executive vice-president for research and development at Biogen, said: "The positive CHMP opinion, which was expedited under the accelerated assessment programme, recognises the compelling efficacy profile of Spinraza and underscores the significant unmet need for an effective SMA treatment in Europe."

Biogen has licensed the global rights to develop, manufacture and commercialise Spinraza from Ionis Pharmaceuticals, with developed the drug alongside Biogen.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.ADNFCR-8000103-ID-801835153-ADNFCR

We currently have 8 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.