March 04, 2010, 9:13 PM EST
By Catherine Larkin and Simeon Bennett
March 5 (Bloomberg) — CSL Ltd., the world’s second-biggest maker of treatments derived from blood, won U.S. clearance to sell a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections.
The Food and Drug Administration announced approval of CSL’s Hizentra in a letter to the company posted yesterday on the agency’s Web site. The medicine will provide a convenient option for patients who want to treat themselves at home instead of receiving intravenous injections from a doctor, the Melbourne-based drugmaker said in a statement.
Hizentra, also known as IgPro20, contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSL’s older Vivaglobin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the U.S.
“We do not expect material market share gains,” Andrew Goodsall, a health-care analyst at UBS AG in Sydney, said in a note to clients today. “They already have a monopoly in that space.” CSL’s nearest competitor, Baxter International Inc., is at least three years away from introducing a rival product, he said.
CSL rose 79 Australian cents, or 2.3 percent, to A$35.59 as of 12:43 p.m. in Sydney, the highest since Feb. 27 last year. The benchmark S&P/ASX 200 Index rose 0.5 percent.
Many people with immune deficiencies are children, and frequent infections can cause life-threatening organ damage or death, according to CSL. Infusions of replacement antibodies help supplement the immune system to prevent infections.
CSL submitted its biologic license application on May 1. While the FDA aims to consider most new drugs within 10 months, the agency said reviews may be extended up to a week after last month’s blizzard shuttered government offices near Washington. Hizentra “did not raise concerns or controversial issues” that warranted review by outside advisers, the FDA letter said.
