Kissei Pharmaceutical said Europe’s Committee for Medicinal Products for Human Use, or CHMP, has recommended revoking EU marketing authorization for Tavneos after concluding that the drug’s benefits had not been shown to outweigh its risks. EMA said on Jan. 30 that it had opened the CHMP review after concerns were raised about the integrity of data from an international phase III trial.
For Kissei, the listed Japanese company that commercializes Tavneos in Japan under a sublicense from VFMRP, the European step has triggered domestic regulatory consultations and an earnings review. Kissei said Tavneos was developed by ChemoCentryx, while sales outside the US in certain countries are handled by CSL, its affiliates and sublicensees under a partnership and license agreement with VFMRP.
| Step | What Kissei disclosed |
|---|---|
| Review trigger | EMA said on Jan. 30 it had started a CHMP review after doubts over the integrity of international phase III trial data. |
| CHMP view | On June 26 local time, CHMP recommended revoking EU marketing authorization because the drug’s benefits had not been shown to outweigh its risks. |
| EU next step | The opinion has been submitted to the European Commission, which is expected to make the final decision. |
| Japan response | Kissei said it reported the view to the Ministry of Health, Labour and Welfare and the PMDA and is consulting on the response. |
| Earnings impact | Under examination. Kissei said it will disclose promptly if any impact becomes clear. |
The EU process is not finished. Kissei said the CHMP opinion has been submitted to the European Commission, which is expected to make the final decision. Tavneos, or avacopan, is used for microscopic polyangiitis and granulomatosis with polyangiitis, two forms of ANCA-associated vasculitis. In background material attached to the filing, Kissei said severe cases can affect organs including the kidneys, lungs and nervous system.
The disclosure does not give investors an end point yet. Kissei has not said what response, if any, will follow in Japan, and it has not put a number on any effect on results. For readers outside Japan, the immediate point is that a Europe-led review of trial data has led Kissei, a Japan-listed sublicense holder, to begin domestic regulatory consultations while the final EU outcome remains pending and the company is still assessing any effect on results.