Novartis In Line For Ofatumumab MS Approval In June

Will Rival Roche's Ocrevus

Novartis’s cancer drug has now been filed for multiple sclerosis in the US, armed with a priority review, and in Europe.

Calendar_June_2020
Date is in the diary for ofatumumab decision • Source: Shutterstock

Novartis AG has been granted a speedy evaluation in the US for its latest multiple sclerosis drug ofatumumab which the company hopes can challenge the domination of Roche's same-in-class blockbuster Ocrevus.

The US Food and Drug Administration has accepted the company’s supplemental biologics license application for ofatumumab for the treatment of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Neurological

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By 

Wales-based group launches with $140m series A.

Supernus Secures Sage With CVR-Supported Deal

 

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Vigil’s Iluzanebart Disappoints In Rare Neurodegenerative Disease

 

The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.

More from Therapy Areas

Sarepta Market Dynamics For Elevidys Imperiled By Second Patient Death

 
• By 

With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.

Supernus Secures Sage With CVR-Supported Deal

 

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

BMS’s Breyanzi Stands To Further Expand Broad Lymphoma Coverage

 

The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.