LONDON, Aug 25 (APM) - Merck KGaA said on Friday its short-course multiple sclerosis drug Mavenclad (cladribine) has been approved in Europe.
The drug has been proven effective for up to four years after just 20 days of oral treatment over two years.
It is the first oral short-course treatment effective across the key measures of disease activity in patients with this condition, including for disability progression, annualised relapse rate and magnetic resonance imaging (MRI) activity.
Approval follows a positives recommendation from the European Medicines Agency's advisory committee, the CHMP, in June (APMMA 53648). Previously, the company said it planned the first European launch of Mavenclad in the UK and Germany this September (APMMA 53756).
Merck's German arm re-iterated the launch timeframe in its Friday statement, and said the selective immune reconstitution therapy's (SIRT) approved indication is as a treatment for highly active relapsing multiple sclerosis (MS). The drug targets lymphocytes thought to be integral to relapsing MS pathology.
"This is an exciting moment and one that will change the way we treat MS," Merck quoted Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London as saying.
"Mavenclad is a [SIRT] which simplifies treatment administration, by giving patients just two short annual courses of tablets in four years. Patients can benefit from the treatment over a longer period of time without having to continually take medication and without the need for frequent monitoring," he added.
The decision comes after a long-fought campaign for the drug's approval. It was rejected in 2011 both in Europe (APMMA 21918) and in the U.S (APMMA 24070), and though it was briefly marketed in Australia (APMMA 20198) and Russia (APMMA 19650), under the trade name Movectro, it was withdrawn after the EU and U.S. setbacks.
The marketing authorisation is based on more than 10,000 patient years' worth of data in 2,700 patients from Phase III CLARITY, CLARITY EXTENSION and ORACLE MS trials.
Data from the Phase II ONWARD study and long-term follow-up data from the eight-year prospective registry PREMIERE were also included. Some patients were observed for up to 10-years.
In post-hoc analysis of the two-year CLARITY trial, it was found Mavenclad reduced annualised relapse rate by 67% and cut the risk of six-month confirmed expanded disability status scale progression by 82%, with no further treatment required in years three and four of the follow up.
The most clinically relevant adverse reactions were lymphopenia and herpes zoster, Merck added.
MS affects more than 700,000 people in Europe with no cure to date, Anne Winslow, president of the not-for-profit organisation, the European Multiple Sclerosis Platform, was also quoted as saying.
"New treatment options will significantly help improve the quality of life of people living with active relapsing MS."
U.S. filing is still planned, though is yet to happen.
/nm/nh
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
