GlaxoSmithKline's Benlysta earns first FDA approval for lupus nephritis as competitors wait in the wings
When GlaxoSmithKline earned its first approvals back in 2011 for Benlysta, it promised regulators it would keep the ball rolling in its pursuit of lupus nephritis, a severe form of the autoimmune disease that can cause renal failure. Now, nearly a decade after the biologic first hit the market, GSK has made good on that promise.
The FDA on Thursday approved intravenous and subcutaneous Benlysta to treat LN, making it the first therapy ever approved for that indication.
The agency based its review on results from the Phase III Bliss-LN study, which showed 43% of lupus nephritis patients in the Benlysta plus standard-of-care arm achieved primary efficacy renal response — a measure of kidney function — compared with 32% of patients in the placebo group. Patients on Benlysta also posted significantly higher response in secondary endpoints, including time to death or a kidney-related complication.
Lupus nephritis is a severe form of systemic lupus erythematosus that can cause late-stage renal failure and require dialysis or kidney replacement in the worst cases. Having a therapy on the market that can cut into the demand for those surgical procedures is a big win for the 60% of 328,000 severe US lupus patients suffering from lupus nephritis each year, GSK said.
“In the four decades I have been caring for people with lupus, we have not been able to achieve remission in more than just one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease,” said Richard Furie, chief of the division of rheumatology and professor at the Feinstein Institutes for Medical Research at Northwell Health and lead investigator of the Bliss study, in a release. “Therefore, it is gratifying to see the rewards of decades of research.”
Expecting an uptick in demand for Benlysta and looking to finally crack into blockbuster territory, GSK has been quickly expanding its manufacturing capacity to drive supply worldwide.
In October 2019, GSK unveiled plans to infuse $139 million plant at its Rockville, MD site to add capacity for Benlysta. The drugmaker chose to retrofit an existing building at the Maryland site, where it already had expertise in producing the injected or infused drug. The investment was used to pay for the demolition of existing suites and the engineering, installation and validation of new equipment.
Then, in May of this year, the British pharma worked out a $231 million deal with CDMO Samsung Biologics to outsource production of its biologic products, including Benlysta, over the next eight years. The deal will initially cover Benlysta, with the first commercial supply expected in 2022. Benlysta generated sales of $747 million in 2019, propping up an otherwise meager biologics portfolio for the Big Pharma. The drug pulled in $252 million in sales in the third quarter, putting it on pace to hit the blockbuster mark.
Meanwhile, challengers from Roche and Aurinia are racing toward the market in lupus, posing an existential challenge to Benlysta’s hold on the hard-to-win market.
In June 2019, Roche posted Phase II data showing blood cancer med Gazyva on top of standard-of-care therapy bested standard of care alone in achieving complete renal response for lupus nephritis patients. The drug earned the FDA’s breakthrough tag back in September 2019. Another challenger, Aurinia’s late-stage lupus nephritis candidate voclosporin, faces an FDA review date of Jan. 22, making it the earliest potential challenger to GSK’s newest indication.