Human Genome Sciences, which had expected the Food and Drug Administration to rule Thursday on its application to market a new lupus drug, will have to wait until March, the Rockville biotech announced today.
Following an FDA advisory committee meeting on Nov. 16 — at which the panel recommended approval of Benlysta by a 13-2 vote — the agency requested additional information from HGS. The company said that it has submitted that information and that the FDA has now postponed a decision until March 10.
In August, the FDA granted a priority review designation to Benlysta. The designation is granted to drugs that, if approved, "offer major advances in treatment, or provide a treatment where no adequate therapy exists," according to the FDA. Drugs granted the designation get an accelerated review, with a goal of six months.
"It's not uncommon for drugs that receive a priority review to get extensions beyond six months," company spokesman Jerry Parrott said today. "About two out of three end up requiring an extension."
HGS stock price did not take a hit on the news, climbing 2.3 percent today.
HGS is developing the drug, which would be the first newly approved lupus treatment in more than 50 years, with partner GlaxoSmithKline of the U.K. GlaxoSmithKline has applied for marketing approval for Benlysta in Europe.
Along with those who suffer from the debilitating autoimmune disease, HGS is banking on federal approval of Benlysta, which would be the company's first FDA-approved product.
The market for lupus drugs, "driven primarily by the launch and uptake" of Benlysta, will quadruple from about $400 million in 2009 to more than $1.6 billion in the U.S., France, Germany, U.K., Italy, Spain and Japan, according to pharmaceutical research company Decision Resources of Waltham, Mass.
In October, H. Thomas Watkins, CEO of HGS, said in a statement that the company has hired its Benlysta sales force and sales management team for the U.S.
"Regulatory applications have been submitted in Europe, Australia, Canada and Switzerland, and we anticipate regulatory submissions in a number of additional countries in the coming months," Watkins said.
Benlysta has undergone phase 3 clinical trials involving more than 2,000 patients with lupus. The trials met their primary endpoints, but the results raised some concerns for the FDA panel last month.
Most of the reservations lay in the drug's labeling. While HGS wants to offer the drug for patients with active lupus, it has not been properly tested as a treatment for severe, life-threatening lupus.
Panel members emphasized Benlysta is not a "magic bullet," but a potential alternative to current treatments for some lupus patients.
"Treating [lupus patients] is heterogeneous. It involves thinking outside the box," said Kathleen Arnsten, patient representative from the Lupus Foundation of Mid- and Northern New York.
Other panelists were concerned with Benlysta's side effects, as infection, depression, suicide and sometimes death were reported in the trials. The panel urged long-term monitoring of side effects.
David Blumenthal, assistant professor of medicine at Case Western Reserve University in Cleveland, was among the two dissenters. He cited the drug's low effectiveness among black patients in its North American study and said the test showing more favorable results was from outside the U.S.
Other concerns involved the combination of Benlysta with other immunosuppressive agents.
Panelist Matthew Liang, professor of medicine at Harvard Medical School, particularly wanted HGS to examine if lower doses of Benlysta could still be effective.
About 5 million people, including 1.5 million Americans, have lupus. The potentially fatal autoimmune inflammatory disease can affect the kidneys, skin, joints and nervous system, among other organs and body functions.
rrand@gazette.net
Following an FDA advisory committee meeting on Nov. 16 — at which the panel recommended approval of Benlysta by a 13-2 vote — the agency requested additional information from HGS. The company said that it has submitted that information and that the FDA has now postponed a decision until March 10.
In August, the FDA granted a priority review designation to Benlysta. The designation is granted to drugs that, if approved, "offer major advances in treatment, or provide a treatment where no adequate therapy exists," according to the FDA. Drugs granted the designation get an accelerated review, with a goal of six months.
"It's not uncommon for drugs that receive a priority review to get extensions beyond six months," company spokesman Jerry Parrott said today. "About two out of three end up requiring an extension."
HGS stock price did not take a hit on the news, climbing 2.3 percent today.
HGS is developing the drug, which would be the first newly approved lupus treatment in more than 50 years, with partner GlaxoSmithKline of the U.K. GlaxoSmithKline has applied for marketing approval for Benlysta in Europe.
Along with those who suffer from the debilitating autoimmune disease, HGS is banking on federal approval of Benlysta, which would be the company's first FDA-approved product.
The market for lupus drugs, "driven primarily by the launch and uptake" of Benlysta, will quadruple from about $400 million in 2009 to more than $1.6 billion in the U.S., France, Germany, U.K., Italy, Spain and Japan, according to pharmaceutical research company Decision Resources of Waltham, Mass.
In October, H. Thomas Watkins, CEO of HGS, said in a statement that the company has hired its Benlysta sales force and sales management team for the U.S.
"Regulatory applications have been submitted in Europe, Australia, Canada and Switzerland, and we anticipate regulatory submissions in a number of additional countries in the coming months," Watkins said.
Benlysta has undergone phase 3 clinical trials involving more than 2,000 patients with lupus. The trials met their primary endpoints, but the results raised some concerns for the FDA panel last month.
Most of the reservations lay in the drug's labeling. While HGS wants to offer the drug for patients with active lupus, it has not been properly tested as a treatment for severe, life-threatening lupus.
Panel members emphasized Benlysta is not a "magic bullet," but a potential alternative to current treatments for some lupus patients.
"Treating [lupus patients] is heterogeneous. It involves thinking outside the box," said Kathleen Arnsten, patient representative from the Lupus Foundation of Mid- and Northern New York.
Other panelists were concerned with Benlysta's side effects, as infection, depression, suicide and sometimes death were reported in the trials. The panel urged long-term monitoring of side effects.
David Blumenthal, assistant professor of medicine at Case Western Reserve University in Cleveland, was among the two dissenters. He cited the drug's low effectiveness among black patients in its North American study and said the test showing more favorable results was from outside the U.S.
Other concerns involved the combination of Benlysta with other immunosuppressive agents.
Panelist Matthew Liang, professor of medicine at Harvard Medical School, particularly wanted HGS to examine if lower doses of Benlysta could still be effective.
About 5 million people, including 1.5 million Americans, have lupus. The potentially fatal autoimmune inflammatory disease can affect the kidneys, skin, joints and nervous system, among other organs and body functions.
rrand@gazette.net
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