Lupus Drug Set For FDA Clearance This Week

A drug for lupus, produced by Human Genome Sciences Inc., is set to get clearance from health regulators, bringing patients the first approved treatment in more than 50 years, and potentially bringing heavy revenue to the company.

Analysts expect the Food and Drug Administration to approve Benlysta by Thursday.

If approved, global sales could top $3 billion in 2015, according to Thomson Reuters consensus forecasts. The company will split Benlysta profits with partner GlaxoSmithKline Plc.

“You’re going to have revenue for a long time from this product. You’re going to become one of the big boys,” Avik Roy, an analyst at Monness Crespi Hardt, told Reuters.

Shares of Human Genome skyrocketed with the hopes that Benlysta will get final approval. The drug was almost entirely written off by investors after early data was inconclusive. Shares fell below 50 cents in March 2009 but jumped later that year when the first positive Benlysta data was released. On Monday, shares were at $25.70 in afternoon trading on NASDAQ.

Approval of the drug has been expected since an advisory panel recommended the drug with a 13-2 vote last November. The FDA, however, delayed its final ruling by three months, which was scheduled for December.

Lupus, a disabling and potentially fatal disease, has been proven hard to treat. It causes the immune system to attack the body’s own tissue and organs, which leads to arthritis, kidney damage, chest pain, fatigue, skin rashes and other problems.

Roughly 5 million people worldwide have the disease. Current drugs are not that effective and many cause severe side effects, such as bone loss from steroids.

During company-funded trials, more patients saw symptoms improve when given Benlysta compared with current standard care.

Advisory panel members who supported the drug said lupus patients needed a new option even though Benlysta was not 100 percent effective in all patients and some experts described its benefits as “mild.”

The FDA will most likely clear Benlysta for “a pretty broad population of moderate to severe” patients, said Michael Yee, analysts for RBC Capital Markets. The agency probably will require prescribing instructions noting that the drug has not been widely studied in black patients or people with severe kidney disease, he said.

Roy said he was “reasonably optimistic” that Benlysta would not get slapped with sharp restrictions, partly due to an uproar from patients who have limited options.

“The FDA is under considerable political pressure to approve the drug and not be antagonistic toward it. Lupus patients have been waiting five or six decades now for an FDA-approved treatment,” Roy told Reuters.

Analysts say the drug will cost up to $30,000 per patient annually, a price in line with biotech medicines for other autoimmune diseases.

European approval is also expected for Benlysta in the second half of the year.

With the drug getting clearance, it is more likely that the company “would be acquired,” said Yee. Johnson & Johnson and Abbott Laboratories, which market big products for other autoimmune diseases, could be interested in an acquisition, as well as Human Genome partner GlaxoSmithKline.

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