The US FDA has approved Sanofi’s multiple sclerosis (MS) drug Lemtrada nearly a year after the regulator denied the drug access to market.
Sanofi’s subsidiary Genzyme announced at the end of last week that Lemtrada (alemtuzumab) had finally been approved in the US to treat relapsing remitting MS, a form of the degenerative disease where patients experience flare-ups of symptoms, such as problems with problems with muscle movement and vision.
The FDA initially rejected Genzyme’s marketing application for the drug’s use in RRMS at the beginning of the year claiming the company “had not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects”.
The decision was a surprise considering the drug’s approval in other regions, such as Europe, and positive trial results that included a comparison study where the drug outperformed standard therapy, Merck Serono’s Rebif (interferon beta-1a).
The rejection led to a backlash from the healthcare community, including a group of doctors who signed an open letter to the FDA urging the agency to re-evaluate its recommendation.
The FDA has now backed the use of the drug, although in a limited population of MS patients who have had an inadequate response to two or more drugs.
Patients who come into this category must access Lemtrada through a restricted distribution programme, which has been developed to ensure the drug is only provided via certified prescribers, healthcare facilities and specialty pharmacies and that patients are part of the Risk Evaluation and Mitigation Strategy (REMS) to further assess the safety of Lemtrada.
On top of this Lemtrada carries boxed warning on its label that notes the risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders.
Despite these measures Sanofi and Gezyme still welcomed the FDA’s decision.
“Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme’s president and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualised relapse rates in the two studies which were the basis for approval.”
Dr Timothy Coetzee, chief advocacy, services and research officer at patient organisation the National MS Society, said: “We are pleased that the voices of the MS community have been recognised and that people with relapsing MS will now have access to a new, needed treatment option.”