GSK, HGS cleared to launch lupus drug with unrestricted label
As expected, the FDA gave the green light for the drug last evening, following a delay in December and earlier FDA advisory panel vote of 13-2 in favor. It's approved for use in patients with disease activity, but not severe activity, who are receiving a range of standard therapies.
"The indication came through just as we proposed," HGS EVP, chief commercial officer Barry Labinger told MM&M. "We've long thought the label ought to reflect how we treated patients in trials. It's not specific to any particular manifestation. It's for a broad, representative SLE population."
The 150-person shared US sales force, many of whom have rheumatology biologics experience, is set to enter the field following training on the drug's label, which lacks a stringent REMS, only a medication guide to inform patients of the risks, and no patient population is restricted.
It does reflect that the drug was not studied in active renal or CNS (severe) lupus patients and highlights an efficacy question in African Americans. African American patients and patients of African heritage participating in two clinical studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion, the FDA said. (HGS has agreed to conduct additional studies to tease this out.)
When prescribing Benlysta, which is the first new treatment for the inflammatory disease in more than half a century, clinicians are advised to only use caution with this population. “We believe physicians will treat and monitor these patients given the dearth of efficacious drugs,” Salveen Richter, an analyst with Collins Stewart, wrote to clients this morning.
Richter is also encouraged by the higher-than-expected Benlysta pricing of about $35,000 per patient per year, vs. an earlier estimate of $30,000. HGS and GSK say that's more than some drugs for multiple sclerosis but less than most biologics for rheumatoid arthritis .
Richter is modeling 2011 Benlysta US sales of $61.4 million, vs. consensus of about $85 million. Other analysts have predicted blockbuster peak sales, as the drug has the potential to cover additional autoimmune treatment areas and post-renal transplant. The company is studying a subcutaneous form of the drug, as well. The current version is delivered via infusion.
Promotional points include the first approved drug in over 50 years, developed specifically for lupus and targeting an underlying cause of the disease. Said Labinger: "We've got a tremendous team of people that have come on board that are very excited about hitting the streets and telling the Benlysta story." They will do so armed with only the prescribing information; sales aids have yet to go through the pre-clearance process.
HGS and GSK will target about 200,000 US patients with moderate and severe forms of lupus (once patients with severe activity become candidates for maintenance therapy, they are fair game for Benlysta). According to company materials cited by Richter, about 66% of Benlysta-eligible patients are insured by commercial payors, another 34% by Medicare and Medicaid.
Other Benlysta marketing efforts for the drug this year have included a patient community for lupus sufferers and their friends and family, located online at usinlupus.com, as well as a direct response print ad that ran in WebMD Magazine. Benlysta.com is expected to go live later today with links to reimbursement advice, patient support materials and medical info.