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The US FDA approved an additional indication for this fluoroquinolone antibiotic in April 2001, as a once daily treatment for uncomplicated skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes. The US FDA originally approved Avelox in December 1999, for treatment of common adult community-acquired respiratory tract infections
The US FDA granted orphan drug status in April 2001, for this proprietary treatment for mucopolysaccharidosis I (MPS I). MPS I is a genetic disease that is characterized by the body’s inability to break down mucopolysaccharides, due to the lack of necessary enzymes. The mucopolysaccharides then accumulate in the body’s cells causing progressive damage to various organs. IDUA is nearly identical to the enzyme present in healthy persons.
TPP – Canada approved an additional indication in April 2001, for the treatment of glabellar lines associated with corrugator and/or procerus muscle activity. A supplemental Biologics License Application was made to the US FDA in January 2001.
The European Medicines Evaluation Agency received a marketing application in April 2001, for Apligraf to treat diabetic foot ulcers and venous leg ulcers. The US FDA approved this skin substitute in June 2000, for the treatment of diabetic foot ulcers > 3 weeks duration.
Phase III trials have begun for Artisone (dapsone, Atrix Laboratories) for the treatment of moderate to severe acne using Atrix’s delivery system that allows the topical administration of water-insoluble drugs. There was approximately a 50% reduction in inflammatory and non-inflammatory lesions in Phase I and II trials. Furthermore, serum dapsone levels were about 1/600 of the level that causes safety concerns with oral dosing. This suggests that Artisone may combine the power of a systemic drug with the safety of a topical drug.
Positive data was reported from Phase I and II trials of HCT-1026 (Nicox SA), a topical formulation of a nitric oxide-releasing derivative of the nonsteriodal anti-inflammatory drug (NSAID) flurbiprofen. A 1% ointment formulation demonstrated significantly greater anti-inflammatory activity than its reference NSAID, flurbiprofen four hours after application.
Schering AG/Berlex is expected to launch its photodynamic therapy product, Levulan Kerastick (5-aminolevulinic acid) in the US soon for the treatment of actinic keratoses of the scalp and face. Levulan was approved by the US FDA in December 1999, and is awaiting approval from TPP – Canada.
Phase II study results were recently reported for AMEVIVE (Alefacept, Biogen). When patients with moderate to severe chronic psoriasis, who had previously been treated with this drug, received another treatment course, approximately half of the patients achieved >50% reduction of their disease, using the Psoriasis Area and Severity Index. Patients maintained their clinical improvement between 5 and 17 months after their course of therapy. AMEVIVE is an immunomodulator that specifically targets a subset of lymphocytes which play a pivotal role in causing psoriasis.