Human Genome’s new lupus drug takes next step to approval

An advisory committee for the Food and Drug Administration (FDA) has voted in flavor to approve the new drug Belimumab for the treatment of lupus.

The Committee voted 13-2 in flavor of Benlysta. The proposed drug includes long-term safety studies from current trials (1,293 currently on drug) as well as several post-marketing studies.

Belimumab is a monoclonal antibody designed to inhibit a protein called B-lymphocyte stimulator, or BlyS, responsible for mediating the maturation of antibody-producing beta cells that attack healthy tissue.

Belimumab showed unexpected positive results in two late-stage studies last year—changing Human Genome’s stock market value–as financial experts project annual sales eventually breaking $1 billion a year. The drug is widely expected to get FDA approval because of its strong data and the lack of alternatives for patients.

“It is a beacon of hope. There hasn’t been, in the history of the disease, a drug aimed specifically at lupus,” said Sandra Raymond, president of the Lupus Foundation of America.

As lupus patients typically have a wide range of differing symptoms, coordinating large clinical trials has been a challenge – this is likely the primary reason drug companies have found it difficult to develop new medications. Although there have been several attempts, apart from this one, all the others have failed.

The FDA will work with representatives and discuss the details of the labeling and marketing specifications before the agency makes a final decision by a tentative Dec. 9 deadline.