By Dean Seal

Eagle Pharmaceuticals said regulators have granted fast-track designation for CAL02, its non-biological bacterial virulence neutralizer and anti-infective agent that's being developed to treat severe community-acquired bacterial pneumonia as an add-on therapy.

Chief Executive Scott Tarriff said Wednesday that the designation allows it to work more closely with the U.S. Food and Drug Administration to advance the new treatment option, as it would be eligible to request a priority review of its new drug application.

The FDA has also granted a Qualified Infectious Disease Product designation for CAL02, the company said.

With that designation, Eagle expects to have eight to 10 years of regulatory exclusivity once its new drug application gets approved.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

June 14, 2023 07:24 ET (11:24 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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