Genzyme ‘confident’ of FDA nod for MS drug
pharmafile | August 29, 2012 | News story | Sales and Marketing | Genzyme, Lemtrada, MS, multiple sclerosis
Genzyme insists it is on course to resubmit an existing oncology drug for the treatment of relapsing multiple sclerosis (RMS), despite being knocked back by US regulators.
Lemtrada (alemtuzumab) is already licensed to treat leukemia under the name Campath, but the Food and Drug Administration has just issued a Refuse to File letter for the new indication.
Genzyme has predicted that Lemtrada, filed with the FDA in June, could earn as much as $2.5 billion a year – although its owner Sanofi forecast just $700 million given the changing nature of the MS market.
Sanofi could have done without this latest obstacle since its $20 billion purchase of Genzyme was based in no small part on Lemtrada’s potential.
But the good news for Genzyme is that the FDA has not requested more information or extra studies – instead it wants the manufacturer to modify its presentation of data sets to make the application easier to follow.
“We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency’s request and resubmit rapidly,” said Genzyme chief executive David Meeker.
Bayer HealthCare is co-promoting the drug in its putative RMS indication: an application to that effect was also made to the European Medicines Agency in June and is ongoing.
The monoclonal antibody targets CD52, a protein found on T and B cells, and treatment depletes the cells thought to cause inflammation of the joints.
Genzyme believes the drug has the potential to reduce MS disease activity, helping to rebalance the immune system after its anti-inflammatory action.
Phase III data has shown that Lemtrada beat the standard injectable treatment, Merck Serono’s Rebif (interferon beta-1a) – but its main competition is Novartis’ Gilenya (fingolimod), the first oral MS treatment to reach the market.
Genzyme has also submitted its once-daily oral MS treatment Aubagio (teriflunomide) for review by the FDA and EMA.
Adam Hill
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