Protalix receives CRL for Gaucher disease treatment
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.”
Watson seeks regulatory approval for generic Adderall XR
PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.
British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.
Shire said Watson’s latest application is distinct from the one it filed in 2007 that resulted in a settlement between the two companies. Under the Hatch-Waxman Act of 1984, Shire has the right to file a patent infringement lawsuit against Watson in response to the latest application.
Patent protection for the drug expires in April 2019.
Savient’s Krystexxa launches in the United States
EAST BRUNSWICK, N.J. — Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.
The drug maker announced the U.S. commercial launch of Krystexxa (pegloticase).
"Since receiving FDA approval for Krystexxa, we have focused on preparing for a successful U.S. launch," said John Johnson, Savient CEO. "Our sales force has completed very thorough and extensive training. We are excited to deploy this highly talented and biologics experienced team into their territories. There has never been a more exciting time in the history of Savient, nor for the chronic gout patients, who have waited so long for a therapy that has the potential to change the course of their lives."