DCA Authorises Six Drugs For Covid-19 Treatment

The drugs approved for Covid-19 treatment are: Roche’s Ronapreve solution, Glenmark’s Fabiflu tablets, Lilly Del Caribe’s Olumiant tablets, and Pfizer’s Paxlovid tablets.

KUALA LUMPUR, March 31 – Malaysia’s Drug Control Authority (DCA) has approved six pharmaceutical products for Covid-19 treatment as of March 18.

They include the Ronapreve solution for injection or infusion manufactured by F. Hoffman-La Roche Ltd in Switzerland, Fabiflu 200mg tablets (Glenmark Pharmaceuticals Limited, India), Olumiant 2mg film-coated tablets (Lilly Del Caribe Inc, Puerto Rico), and Olumiant 4mg film-coated tablets (Lilly Del Caribe Inc, Puerto Rico).

The Paxlovid 150mg film-coated tablets and Ritonavir 100mg film-coated tablets (Pfizer Manufacturing Deutschland GmbH, Germany) and the Paxlovid 150mg film-coated tablets and Ritonavir 100mg film-coated tablets (Pfizer Ireland Pharmaceuticals, Ireland) were given conditional approvals earlier this month.

Health Minister Khairy Jamaluddin told Pandan MP Wan Azizah Wan Ismail, in a written parliamentary reply on March 22, that the National Pharmaceutical Regulatory Agency (NPRA) is also in the process of evaluating several other Covid-19 antiviral treatments.

Ronapreve, also known as REGEN-COV in the United States, is given as a single treatment by infusion (drip) into a vein or by injection under the skin. 

It was widely approved for emergency use last year in over 20 countries, including in the United Kingdom and the US, though the latter, via its Food and Drug Administration (FDA) later revised its emergency use authorisation for REGEN-COV on January 24, 2022, to limit its use, as the drugs are unlikely to work against the Omicron coronavirus variant.

Fabiflu is a generic favipiravir-based drug produced in India to treat mild to moderate cases of Covid-19 infections in adults. Favipiravir is an antiviral medication used to treat influenza originally developed in Japan.

Olumiant is used to treat adults with moderately to severely active rheumatoid arthritis, but is being considered by the European Medicines Agency (EMA) to treat hospitalised Covid-19 patients.

The product registration holder (PRH) for the Ronapreve solution is Roche (M) Sdn Bhd, while Glenmark Pharmaceuticals (Malaysia) Sdn Bhd is PRH for the Fabiflu tablets. The PRH for the Olumiant and Paxlovid film-coated tablets are Zuellig Pharma Sdn Bhd and Pfizer (Malaysia) Sdn Bhd, respectively.

Khairy previously said that Malaysia will receive the first shipment of Pfizer’s Paxlovid Covid-19 oral antiviral treatment this month. Malaysia had purchased 110,000 treatment courses to be given to high-risk individuals.

Khairy said the government is also looking at procuring two other Covid-19 antivirals, Merck’s Molnupiravir and AstraZeneca’s Covid antibody drug, but it has yet to be finalised.

The Sarawak state government had also announced plans to acquire Paxlovid, following its purchase of Roche’s Ronapreve, which has been available at Sarawak’s public hospitals since last year.

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