November 17, 2010 by staff
Yesterday, the advisory panel backs drug Human Genome Benlysta lupus. Benlysta could become the medicine for the first time in half a century to win approval for the fight against the debilitating and potentially fatal autoimmune disease.
It is envisaged that this news will transform the company from a non-profitable segment of the Star of the Industry. Analysts forecast annual global sales to 2.2 million in 2014.
The FDA Arthritis Advisory Committee voted 13-2 in favor of Benlysta approval for the treatment of lupus erythematosus. While discussions focused primarily on the efficiency benefit of mild Benlysta, the lower response rate found in patients of African origin and design of the test, the panel voted 10-5 that the data showed substantial evidence of effectiveness. In terms of safety profile, the vote was 14-1 in favor of the approval given the small number of patients.
The proposed drug includes theanlysis of long-term safety of ongoing trials (1293 currently on drugs) and several post-marketing studies.
Lupus is a disease that causes the immune system attack the body’s own tissues and organs and can lead to arthritis, kidney damage, chest pain, fatigue, skin rashes and other problems. Organ damage can be fatal, and current therapies have serious side effects.
But FDA reviewers said that this medicine may increase the risk of death, infection, or psychiatric problems including suicide.
Human Genome Sciences (HGS) is a commercially focused biopharmaceutical company. The company has three products in late stage clinical development: BENLYSTA for lupus erythematosus (SLE), ZALBIN for chronic hepatitis C, and raxibacumab of inhalation Anthrax.
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