European recommendation for GSK’s lupus drug Benlysta
pharmafile | May 23, 2011 | News story | Sales and Marketing | Benlysta, CHMP, GlaxoSmithKline, Lupus
GlaxoSmithKline’s first-in-class lupus drug Benlysta has been given a major boost by regulators in the European Union.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended it for marketing authorisation, a step which invariably leads to a full approval.
These are heady times for GSK and its development partner Human Genome Sciences, with Benylsta (belimumab) receiving US approval two months ago when it became the first new treatment for autoimmune disease lupus to be licensed by the FDA in more than 50 years.
The EU recommendation is for Benlysta as an add-on treatment for adults with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity despite taking standard therapy.
The CHMP reviewed data from two phase III studies (BLISS-52 and BLISS-76) of belimumab, the first BLyS-specific inhibitor, which enrolled nearly 1,700 adults with this form of the disease.
“A positive recommendation from the CHMP is a major milestone in the clinical development programme for Benlysta,” said Moncef Slaoui, chairman of GSK R&D.
HGS chief executive H. Thomas Watkins said: “We are well along in building our own HGS commercialisation team in Europe and, assuming a positive EC decision, we look forward to working alongside GSK to make Benlysta available to patients.”
Further applications have been made in Canada, Australia, Switzerland, Russia, Brazil and the Philippines.
Lupus is potentially fatal, and disproportionately affects females – particularly Afro-Caribbean women – with three times as many new cases of the disease in this group compared to white women.
The most common side effects of the drug are nausea, diarrhoea, and pyrexia (fever). The CHMP said Benlysta’s mechanism of action could increase the potential risk of developing infections and that, as an immunomodulating drug, a potential risk for malignancies cannot be ruled out.
Consequently a pharmacovigilance plan for Benlysta will be implemented as part of the marketing authorisation.
In the US the FDA approved Benlysta after a fast-track review in recognition of its potential to be a major advance in the disease area – on the proviso that it proved its safety record once it hit the market.
The regulator wants more safety and efficacy information and stronger warnings for patients about side effects, with GSK and HGS producing a Medication Guide and conducting an additional clinical trial in a particular subgroup of patients.
Adam Hill
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