1. Scrip
  2. >>Business
  3. >>Strategy

Merck KGaA Foresees Mid-2019 US Launch Of Oral MS Therapy Mavenclad

 
• By Sten Stovall

German Merck tells Scrip Mavenclad's long spell in the regulatory 'wilderness' allowed it to amass deep safety and efficacy data that should help the oral MS drug's commercial prospects.

Nerve cells
Mavenclad Already has approval in Europe to treat highly active relapsing MS • Source: Shutterstock

Merck KGaA's oral multiple sclerosis drug Mavenclad (cladribine) should finally get approved and launched in the US in the first half of 2019, executives at the German company told Scrip. It will be helped in part by the deep data collected during its difficult regulatory journey spanning nine years,which should differentiate the therapy from other MS drugs, they believe. 

Mavenclad has had a difficult past: The German drug maker first filed the product in 2009 but was pushed back...

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
Start Free Trial

Already a subscriber?

More from Strategy

Glenmark Fortifying Branded Play, Shifts Focus To High Margin Products

 
• By Anju Ghangurde

Glenmark signals thrust on high margin products, while exiting tail end brands as part of efforts to emerge as a branded company. In-licensed assets like Brukinsa and Tevimbra are seen as pivotal to driving growth alongside.

Discontinuations For Viking’s Oral Obesity Drug VK2735 Scare Investors

 
• By Joseph Haas

Analysts lauded the 13-week weight-reduction rates Viking’s oral dual GLP-1/GIP agonist showed in Phase II, but the firm’s stock tumbled 42% due to high discontinuation rates.

Egetis Eyes Swift US Submission For Emcitate

 
• By Kevin Grogan

The Sweden-based firm is set for talks with the FDA on the regulatory path for its MCT8 deficiency candidate.

Leo Keeps On Profitable Path With Solid H1 Sales Growth

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug Adbry is performing well despite strong competition from Sanofi/Regeneron’s Dupixent.

More from Business

Boehringer Expands Eyecare Horizons With Palatin Collaboration

 
• By Andrew McConaghie

The German company already had four eye disease candidates in Phase II development and sees promise in Palatin’s novel melanocortin receptor modulators.

Egetis Eyes Swift US Submission For Emcitate

 
• By Kevin Grogan

The Sweden-based firm is set for talks with the FDA on the regulatory path for its MCT8 deficiency candidate.

Stock Watch: Pfizer Relights Q2 Earnings Season’s Fire

 
• By Andy Smith

Pfizer showed how to come out on top with investors during earnings season. Post strong sales growth – and avoid mentioning tariffs, most favored nation pricing or Medicare modernization impacts.