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KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.
The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.
The FDA raised questions about clinical trials, chemistry, manufacturing and controls, Protalix said. The drug maker said that when it submitted the application, the full data were not available, but that it would request a meeting with the FDA to clarify the path to regulatory approval “as soon as possible.”