Double Delight For Novartis At The CHMP

Backing For MS Drug Mayzent And Isturisa For Cushing's

Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis drug which is key to the company's ambitions for growth in the neurology space.

Hurdles
Mayzent Over Final Hurdle Before European approval • Source: Shutterstock

The latest meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, has provided a double boost for Novartis AG with recommendations for its multiple sclerosis treatment Mayzent and Cushing’s syndrome therapy Isturisa.

The CHMP has adopted a positive opinion for Mayzent (siponimod) for the treatment of adults with active secondary progressive MS, ie, those who have evidence of inflammatory activity on an...

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 New Products

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By 

One Phase III trial hits but a second study misses by a mile.

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By 

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

More from Scrip

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Astellas Gets CLDN.18.2-Targeted ADC From China’s Evopoint

 
• By 

Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback