La Jolla Pharmaceutical Asks European Regulators to Withdraw Riquent Application
Drug developer La Jolla Pharmaceutical Co. asked the European Medicines Agency to withdraw the company's application for its lupus renal disease treatment candidate Riquent, saying it would need more time to compile additional data the regulatory body requested.
In a statement, the company said it believes already ongoing additional studies would provide the necessary data, but that it would not be available within the timeframe allowed by regulations. La Jolla plans to refile for approval when the new data is compiled.
Approximately 50 percent of lupus patients have renal disease, the company said, which leads to renal failure, a need for dialysis. It is the leading cause of death among lupus patients, according to the company.
Shares of La Jolla fell 6 cents to $3.59 in morning trading on the Nasdaq.
Drug developer La Jolla Pharmaceutical Co. asked the European Medicines Agency to withdraw the company's application for its lupus renal disease treatment candidate Riquent, saying it would need more time to compile additional data the regulatory body requested.
In a statement, the company said it believes already ongoing additional studies would provide the necessary data, but that it would not be available within the timeframe allowed by regulations. La Jolla plans to refile for approval when the new data is compiled.
Approximately 50 percent of lupus patients have renal disease, the company said, which leads to renal failure, a need for dialysis. It is the leading cause of death among lupus patients, according to the company.
Shares of La Jolla fell 6 cents to $3.59 in morning trading on the Nasdaq.

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