It’s been five months since new lupus drug Benlysta became the first new U.S. Food and Drug Administration-approved lupus treatment in 56 years. Since receiving FDA approval, GlaxoSmithKline (NYSE:GSK) and drug partner Human Genome Sciences (NASDAQ:HGSI) have been working to build the drug’s sales in the United States while also seeking approval in additional markets.
British pharmaceutical company GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, has partnered with HGS on Benlysta since 2006. The Lupus Foundation of America estimates that lupus affects 5 million people worldwide. Patients have been waiting years for a new lupus treatment and their rheumatologists are well aware of the new drug.
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“The fundamentals of the Benlysta launch are positive,” said GSK spokeswoman Holly Russell. “The HGS and GSK sales teams have called on 90 percent of the key rheumatology accounts with awareness of Benlysta among rheumatologists at virtually 100 percent.”
BioTrends Research Group has been conducting studies on the commercialization of Benylsta. In its most recent report issued earlier this month, the group surveyed rheumatologists are “maintaining enthusiasm” for Benlysta but uptake of the drug faces two challenges: the lag in reimbursement approval and uncertainty about who is an “appropriate” patient for the drug. But 80 percent of rheumatologists surveyed anticipate starting some of their patients on Benlysta within the next month, BioTrends said.
Here’s a look at some key dates this year for Benlysta:
March 9: The FDA announces approval of Benlysta, which was discovered by HGS and co-developed with GlaxoSmithKline. Two weeks following approval, the drug became available in distribution channels.
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July 6: Health Canada approves Benlysta; GSK and HGS announce regulatory approval in Canada on July 12. The companies expect that Benlysta will become available to patients in Canada in September. According to Lupus Canada, the disease affects about 34,000 Canadians.
July 14: Two days after announcement of Benlysta’s regulatory approval in Canada, the European Commission grants marketing authorization for Benlysta as an add-on therapy in adult lupus patients.
July 21: In second-quarter financial results, HGS reports $7.8 million in Benlysta sales. That total does not include $1.2 million in deferred revenue for Benlysta shipped to distributors but not yet delivered to healthcare providers.
What’s next? Regulatory applications have been submitted and are currently under consideration in Australia, Switzerland, Russia, Brazil, Israel, Colombia, Singapore, Taiwan and the Philippines. GSK said it also expects to file regulatory submissions in additional countries this year.
