Japan health panel delays emergency approval of Shionogi COVID-19 pill

TOKYO, July 20 (Reuters) – A Japanese health ministry panel on Wednesday delayed emergency approval for an oral treatment against COVID-19 that has been developed by Shionogi & Co. (4507.T).

Japanese drugmaker Shionogi’s COVID-19 pill Xocova, also known as S-217622, is seen in this handout picture delivered to Reuters on July 20, 2022. Shionogi & Co. Ltd./Handout via REUTERS

Health experts on the panel voted to support a motion that they would await more data from ongoing clinical trials and continue discussions on the drug, dealing another blow to Shionogi’s global ambitions for the antiviral pill.

Authorities had postponed a decision last month on the drug known as S-217622, which Shionogi hopes will compete with products from U.S. drugmakers Pfizer (PFE.N) and Merck & Co. (MRK.N) that have already been approved in Japan and elsewhere.

The company has signed an agreement to sell about a million doses to the Japanese government, pending the drug’s approval.

Chief Executive Isao Teshirogi has said that annual production of the drug could reach 10 million doses. It has received U.S. government support for a global Phase III trial. read more

Speculation about the treatment has sent Shionogi’s shares on a rollercoaster ride.

Last month a health ministry panel postponed ruling on the drug because of uncertainty over its effectiveness as well as animal studies showing it could pose a risk to pregnancies.

Shionogi this month said it was preparing to seek approval in China for the drug, shown in pre-clinical studies to display high antiviral activity against the Omicron variants BA.4 and BA.5. read more

Some members of the health panel said that while trial data had not proved the effectiveness of the drug, the results were positive enough to grant emergency approval to help to tackle a seventh wave of infections and possibly reduce the incidence of so-called “long COVID” effects in patients.

New infections in Japan exceeded 150,000 on Wednesday, the Nikkei newspaper reported.

Reporting by Rocky Swift Editing by Andrew Heavens and David Goodman

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