Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) joined the JAK inhibitor pile-on Oct. 6 with new measures to reduce the risk of major heart problems and malignancies in people taking Pfizer Inc.’s Xeljanz (tofacitinib).
Exo Therapeutics Inc. has completed an oversubscribed series B financing for $78 million allowing the small-molecule company to continue developing therapies for treating cancer and inflammation.
Exo’s pipeline, created from its Exosight platform, has preclinical candidates that bind exosites, which are distal binding pockets for reprogramming enzyme activity. The exosite drugs include structural and computational biology, protein engineering and DNA-encoded libraries.
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