- The Food and Drug Administration has cleared for market a new version of GlaxoSmithKline's lupus drug, an approval that will surely beef up the drugmaker's immunology and inflammation portfolio.
- A subcutaneous (SC) formulation of Benlysta (belimumab) should begin hitting specialty pharmacy shelves in the U.S. by late August, according to a Friday statement from GSK. The treatment is for adults with active systemic lupus erythematosus (SLE), the most common form of the autoimmune disease, who are already receiving standard of care therapy.
- Benlysta broke into the stateside pharmaceutical market back in 2011 as an intravenous (IV) medication and was the first lupus drug to receive FDA approval since 1955, according to the American College of Rhematology.
Since the completion of its more than $20 billion asset swap with Novartis in 2015, GSK has received the bulk of its revenue from three core units: respiratory, HIV and established medicines. In fact, drugs from those segments accounted for nearly 98% of the $4.36 billion in revenues the British drugmaker reported during the second quarter of 2017.
The odd man out, as it seems, is the company's immuno-inflammation business, which has just one marketed product in Benlysta.
GSK has seen ramped up sales for the drug in the last few years. Benlysta sales were £78 million ($102 million) in the second quarter of last year, for example, and increased 19% to £93 million ($122 million) during the same period in 2017.
Those revenues are likely to rise, however. GSK said during its second quarter earnings call on Wednesday that it would be increasing its focus —and allocating its cash —to four key areas: respiratory, HIV, oncology and immunology.
Not only does the FDA's decision add another administration option to the Benlysta franchise, but self-administered SC formulations can also help increase patient adherence, particularly when the alternative requires a potentially burdensome or time-consuming trip to the doctor's office.
"Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta," Vlad Hogenhuis, GSK's head of specialty care, said in the July 21 statement. "The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions."
The new Benlysta approval hinged on data from a late-stage pivotal study that evaluated northwards of 800 SLE patients. Results from that trial showed nearly 61% of patients treated with SC belimumab and standard of care had reduced disease activity versus a 48% in the control arm.