New Lupus drug marching towards approval

By Dr. Ananya Mandal, MDMar 7 2011

A new drug for lupus from the Human Genome Sciences Inc is all set to get clearance in the US this week. If all goes through, this drug will offer patients the first approved treatment option in a half-century, setting the manufacturer up for huge sales.

The drug, trade named Benlysta is one the most closely watched medicines of the year. Annual global sales may top $3 billion in 2015, according to Thomson Reuters consensus forecasts. The company will split Benlysta profits with British partner GlaxoSmithKline Plc. Human Genome shares have soared with hopes for Benlysta. Investors had largely written off the drug after early data were mixed. Shares fell below 50 cents in March 2009 but jumped later that year when the first encouraging Benlysta data was released. On Monday, Human Genome shares were up over 0.5 percent to $25.74 on the Nasdaq. Shares may gain about $2 on a positive FDA ruling, RBC Capital Markets analyst Michael Yee said.

This clearing expected on Thursday has been on the cards since an advisory panel recommended the drug in a 13-2 vote last November. In December, the FDA delayed a final decision by three months.

Lupus is a severe and potentially fatal disease that has proved difficult to treat. It causes the immune system to attack the body’s own tissue and organs, leading to arthritis, kidney damage, chest pain, fatigue, skin rashes and other problems. The organ damage can be fatal. An estimated 5 million people worldwide have the disease. Current drugs often fail to help or cause harsh side effects, such as severe bone loss from steroids. The last drug approved specifically for lupus was the antimalarial medicine quinacrine in 1958.

With Benlysta symptoms improve compared with current standard care, which typically includes immunosuppressant drugs such as Roche’s CellCept and steroids such as prednisone. Benlysta, known generically as belimumab, is given once a month by intravenous infusion. Analysts expect the drug will cost around $30,000 per patient annually, a price in line with biotech medicines for other autoimmune diseases. It acts by inhibiting BLyS, a protein in the body that exists to keep B-cells functioning normally. B-cells make antibodies that prevent infection. In lupus patients, B-cells are overstimulated and make antibodies that attack the body.

Not all are too excited with Benlysta. Some experts described the drug’s benefits as mild. The agency probably will require the prescribing instructions to note the drug has not been widely studied in black patients or people with severe kidney disease. European approval for the drug is expected in the second half of the year.