(Reuters) -The U.S. health regulator has approved Citius Pharmaceuticals’ blood cancer therapy, Lymphir, for relapsed patients who have received at least one prior treatment and asked for the addition of a boxed warning about the risk of a rare blood condition, the company said on Thursday.
Shares of the company fell 1.7% to 89 cents in premarket trading.
The Food and Drug Administration had declined to approve the therapy last year, seeking additional product testing data.
The prescribing information for Lymphir carries the health regulator’s serious “boxed warning”, flagging a life-threatening risk of a rare blood condition called capillary leak syndrome.
Capillary leak syndrome causes blood plasma to escape through tiny blood vessels and leads to a rapid drop in blood pressure.
Lymphir, Citius’ first approved treatment, is expected to be launched within the next five months and is approved for certain adult patients with relapsed cutaneous T-cell lymphoma, a group of rare blood cancers that affects the skin.
The cancer has an incidence rate of 8.55 in 1 million people in the United States, according to government data.
The FDA’s approval is based on data from a late-stage trial, which showed that 36.2% of patients treated with Lymphir showed partial or complete response to the treatment while reducing skin disease in 84% of patients in the study.
Citius acquired the licensing rights to Lymphir from India’s Dr. Reddy’s Labs for an upfront payment of $40 million. Dr. Reddy’s is also entitled to an additional $40 million in milestone payments related to U.S. approval of the therapy.
(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
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