Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.
Once again, Amgen Inc.’s Tavneos (avacopan) is under U.S. FDA scrutiny, as the agency alerted patients and doctors March 31 about 76 cases of drug-induced liver injury, including eight deaths, with “reasonable evidence of a causal association” with the drug.
Chemocentryx Inc. has divulged chemokine CXCR6 receptor antagonists reported to be useful for the treatment of cancer, autoimmune hepatitis, ischemia-reperfusion injury, myocardial ischemia, autoimmune disease and inflammatory disorders.
Chemocentryx Inc. has described aryl sulfonyl (hydroxy) piperidines acting as C-C chemokine receptor type 6 (CCR6) antagonists reported to be useful for the treatment of atopic dermatitis, psoriasis, endometriosis, periodontitis, rheumatoid arthritis, scleroderma, psoriatic arthritis and inflammatory disorders.
Chemocentryx Inc. has divulged azetidinyl-acetamides acting as atypical chemokine receptor 3 (ACKR3) antagonists reported to be useful for the treatment of cancer and inflammatory disorders.
Amgen Inc. is paying $3.7 billion in cash to buy Chemocentryx Inc. The deal, with Amgen paying $52 per share for Chemocentryx stock, brings Amgen Tavneos (avacopan), a first-in-class medicine for treating antineutrophil cytoplasmic antibody-associated vasculitis, which destroys small blood vessels.
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 FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.”
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
