FDA approves special distribution program for Tysabri marketing
FDA approved Biogen-Idec's application to resume marketing Tysabri (natalizumab) subject to a special restricted distribution program. Tysabri is a monoclonal antibody used to treat patients with relapsing forms of multiple sclerosis to reduce exacerbation frequency. It is meant for patients who have not responded adequately to, or cannot tolerate, other treatments for MS and is indicated for use as monotherapy because not enough is known about how use with other immune system-modifying drugs could impact risk.
Tysabri was approved in November 2004 but was withdrawn by the manufacturer in February 2005 after three clinical trial patients developed progressive multifocal leukoencephalopathy (PML) and two patients died.
FDA said Tysabri can be made available under the company's TOUCH risk management program that includes these features: 1) the drug will only be prescribed, distributed, and infused by prescribers, infusion centers, and pharmacies registered with the program; 2) Tysabri only will be administered to patients enrolled in the program; 3) prior to initiating therapy, health care professionals must obtain a patient's MRI scan to help differentiate potential future MS symptoms from PML; and 4) patients on Tysabri are to be evaluated at three and six months after the first infusion and every six months after that, with their status reported regularly to the company.
Baxter Healthcare agrees to fix manufacturing problems
Baxter Healthcare Corp. and two top company executives signed a consent decree of condemnation and permanent injunction with FDA for certain infusion pumps. They agreed to stop manufacturing and distributing within the U.S. all models of the Colleague Volumetric Infusion Pump and the Syndeo Patient-Controlled Analgesic Syringe Pump until they correct manufacturing deficiencies and the devices are made in compliance with FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices.
The decree requires the company to hire an independent consultant to inspect its infusion pump facilities and certify to FDA that corrections have been made. FDA will allow the company to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo pumps that already were in the hands of customers before Oct. 12, 2005.
The agency said its most recent inspection of Baxter's Round Lake facility, conducted June 20-30, 2005, found deficiencies with the CGMP and QS requirements, including the firm's failure to implement adequate management controls over its quality system operations and corrective and preventive actions procedures. Design defects relating to the reliability of both pump models also were found. Baxter has put a worldwide hold on both pumps due to design defects.
If corrective action under the decree is completed and Baxter is allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its domestic infusion pump facilities annually for at least four years, with inspection results reported directly to FDA. If Baxter fails to comply with any decree provision, or violates FDA law or regulations, the agency may order the firm to again stop manufacturing and distributing, recall the product, or take other action.
New safety information added to Ketek labeling
After a safety assessment of Sanofi-Aventis' antibiotic Ketek (telithromycin), FDA said health practitioners and patients should be aware of rare but potentially serious health risks. Ketek is the first FDA-approved ketolide class antibiotic, and is indicated for treating acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia of mild-to-moderate severity, including pneumonia caused by resistant strep infections. FDA said Ketek has been associated with rare cases of serious liver injury and liver failure, with four reported deaths and one liver transplant after administration. The company is revising the labeling to reflect the safety concern.