Two Massachusetts biotechs have made history by becoming the first companies to win clearance to market novel human immune-system treatments from the U.S. Food and Drug Administration. The companies are Moderna Therapeutics and Pharmacyclics, the latter of which is in a collaboration with drugmaker Johnson & Johnson.
According to a joint statement from the companies, the agency has approved Moderna’s technology to increase the function of monoclonal antibodies and lower the risk of rejection, helping it become the first company to submit an application to market a treatment that relies on messenger RNA. The newly cleared drugs would treat CD38-positive solid tumor cancers, such as non-small cell lung cancer, and the blood diseases myeloma and acute myeloid leukemia. They would both be taken orally, and neither were evaluated for safety.
As the first company to offer effective therapies based on messenger RNA, for which the FDA is exercising discretion, Moderna and Pharmacyclics have created “a new era of commercial-stage products” that have “potential to benefit patients around the world,” the pair said in a joint statement.
The same day, the agency also approved the first booster shot aimed at reversing the harmful side effects of an existing therapy — TPA, which is used to help patients who have suffered a hemorrhagic stroke or chest hemorrhage. TPA is a standard treatment for bleeding-related emergency surgery. The FDA’s approval “could transform stroke treatment worldwide,” according to the agencies’ statement.
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