|Name/Company||Approval Dates and Comments|
The US FDA and Health Canada approved this biologic in April 2009 for the treatment of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Health Canada approved this antiretroviral agent in April 2009 for the treatment of HIV infection to be used once-daily in treatment-naïve adults in combination with other antiretroviral agents such as ritonavir. This product, dosed at 600mg twice-daily, coadministered with 100mg ritonavir twice-daily, is already approved for treatment-experienced patients.
The US FDA accepted in April 2009, as complete for review, Theravance’s response to the February 2009 Complete Response Letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections. The FDA’s approval will allow Theravance to advance their application through the FDA review process.
In February 2009, The US FDA notified the manufacturers of licensed botulinum toxin (BTX) products that there is a need to strengthen warnings in product labeling and add a boxed warning that details the risk of adverse events when the effects of the toxin spread beyond the injection site. In addition, the FDA has advised the manufacturers that development and implementation of a Risk Evaluation and Mitigation Strategy is necessary to ensure that the benefits of the product outweigh the risks. This strategy would include a communication plan to provide more information about the risk for distant spread of the BTX effects after local injection, as well as information to explain that BTX products cannot be interchanged. This strategy would also include a medication guide that explains the risks to patients, their families and caregivers. The FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects. BTX products are FDA-approved for temporary improvement in the appearance of glabellar lines, treatment of strabismus, blepharospasm, cervical dystonia, and primary axillary hyperhidrosis. The FDA urges both healthcare professionals and patients to report side-effects from these products to the FDA’s MedWatch Adverse Event Reporting Program, online at www.fda.gov/medwatch/report.htm.
Trubion Pharmaceuticals, in collaboration with Wyeth Pharamaceuticals, announced in March 2009 that it has initiated a Phase I/II dose-escalation clinical trial for SBI-087, a humanized small modular immunopharmaceutical drug candidate that acts against the CD20 antigen, for the treatment of systemic lupus erythematosus (SLE). The study will enroll patients who were diagnosed with SLE more than 6 months before the beginning of the study. Diagnosis is based on the American College of Rheumatology Revised Criteria. In preclinical data, a single dose of SBI-087 resulted in dose-dependent B-lymphocyte depletion in peripheral blood and lymphoid tissues that was more profound and sustained when compared with rituximab.