FDA knocks back Merck KGaA’s oral MS drug
pharmafile | March 2, 2011 | News story | Sales and Marketing | Cladribine, EMD Serono, FDA, MS, Merck KGaA, Movectro, multiple sclerosis, oral MS drugs
US authorities have turned down Merck KGaA’s new drug application for its oral relapsing-remitting multiple sclerosis treatment Movectro.
The FDA told the German company that more information is required: specifically, it wants extra detail on safety risks for Movectro (cladribine).
It is a blow for Merck, which will now either have to provide additional analyses for Movectro or further studies.
But the decision will benefit rival company Novartis, whose own oral MS drug Gilenya (fingolimod) gained US approval last year and received a positive opinion from the CHMP last month.
Unsurprisingly Merck intends to request a meeting with the FDA to see what happens next – and whether existing clinical data or that from ongoing studies can tip the balance.
Several trials are fully enrolled, with top-line results from the CLARITY EXTENSION and ORACLE MS studies expected by the end of the year. Those from another study, ONWARD, should be available before June 2012.
The FDA acknowledged in its complete response letter that evidence of Movectro’s effectiveness was provided by the original CLARITY study.
“We look forward to working with the FDA to address the safety issues in its letter and will continue to move toward identifying a potential path that provides patients and physicians the opportunity to have access to Cladribine Tablets in the treatment of MS,” said Fereydoun Firouz, president of Merck’s US subsidiary EMD Serono.
But the FDA’s continued lukewarm response on Movectro’s safety – it also sent Merck a ‘refuse to file’ letter in early 2010 – extends a run of disappointments in the development of this drug.
Although approved last year in Australia and Russia as a treatment of relapsing-remitting MS, Merck withdrew Movectro’s European licence application last month.
This pre-empted a European Commission decision expected in April, but after two negative CHMP opinions on Movectro in September, and then another in January, Merck sensed which way the wind was blowing.
The company expects to resubmit after the outcomes of CLARITY EXTENSION, ORACLE and ONWARD are known.
Adam Hill
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