WHO Publishes Updated List of COVID-19 Medicines, APIs

The coronavirus disease 2019 (COVID-19) infections and deaths continue to be reported across the globe creating demand for more appropriate medicines and associated active pharmaceutical ingredients. (1)

The United Nations specialized agency responsible for international public health, the World Health Organization (WHO), says between March 27 and April 23 there were 2.8 million new cases of COVID-19 globally. At least 16 000 people died from the diesase within the same period. The new cases and deaths for the period reflected a decline of 23% and 36% respectively. (2)

However, contrary to this overall trend, "increases in reported cases and deaths continued to be seen in the South-East Asia and Eastern Mediterranean regions and in several individual countries elsewhere,” according to WHO's update.

By the end of April 2023, a total of  764 million COVID-19 cases had been confirmed globally since the outbreak in the first quarter of 2020 with at least 6.9 million deaths.

Since early 2020 several antiviral medications have been recommended for the treatment  COVID-19, especially for those at risk of getting very sick.

The antiviral treatments are designed to target specific parts of the virus in a bid to suppress further multiplication in the body hence averting severe illness and death. These antivirals include Nirmatrelvir with Ritonavir (Paxlovid), Remdesivir (Veklury) and Molnupiravir (Lagevrio).

In April 2023, the WHO published an updated list of at least 53 COVID-19 medicines and active pharmaceutical ingredients that have either been prequalified, under assessment or whose assessment has been cleared but are yet to be prequalified because of outstanding good manufacturing practices (GMP) issues. The EOI for the WHO listed medicines and APIs prequalification had been published between 10 July 2020 and 15 January 2022.

More than 13 firms have been prequalified including four for APIs, one for biotherapeutic products (BTP) and eight for finished pharmaceutical products (FPP).

Another 15 firms for API and FPP are under assessment while an application by India's Dr Reddy for a FPP, has its assessment cleared but awaits conclusion of outstanding GMP issues.

Indian pharmaceutical companies dominate the WHO list of COVID-19 medicines and APIs that have been prequalified or still under assessment up to December 2022.

At least 13 firms have been prequalified for the finished pharmaceutical products of Molnupivar 200mg and Nirmatrelvir 150mg.

For the API prequalification seven Indian firms were prequalified Molnupiravir and Nirmatrelvir while four Chinese companies were prequalified for the same active pharmaceutical ingredients.

Pharmaceutical companies from Cyprus, Greece, USA, UK, Ukraine, Vietnam, Republic of Korea, Pakistan and Ireland were among those whose application were prequalified.

The prequalification of the COVID-19 medicines and APIs came at a time when some of the pharmaceutical firms have struck deals for partnerships to enhance their global market share of the products.

For example, India's Hetero Group confirmed in December 26, 2022 it had received WHO Prequalification of Medicines Program approval for its generic version of COVID-19 oral antiviral treatment candidate nirmatrelvir.  (3)

"This is the first prequalification for a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’, which the WHO called, the best therapeutic choice for high-risk patients to date," the company said in a statement.

At the height of the COVID-19 pandemic WHO made a strong recommendation for nirmatrelvir and ritonavir for patients with mild and moderate symptoms but were at highest risk of hospital admission, such as unvaccinated, aged, or immunosuppressed patients.

Hetero launched a combined pack dubbed NIRMACOM, which is  manufactured at the company's facilities in India and contains nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet).

Hetero Group's managing director Dr. Vamsi Krishna Bandi termed the WHO Prequalification for NIRMACOM "a significant milestone in the fight against COVID-19 as it allows us to expand access to this important innovative antiretroviral drug to people in need."

 "We are committed to making NIRMACOM available faster at affordable prices across 95 low and middle income countries including India,” said Bandi.

Earlier, in March 2022, Hetero entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool for manufacturing and sale of a generic version of Pfizer’s COVID-19 oral antiviral treatment candidate nirmatrelvir, which is co-packaged with low dose ritonavir (nirmatrelvir; ritonavir). (4)

References

1. https://extranet.who.int/pqweb/news/status-covid-19-medicines-and-active-pharmaceutical-ingredients-apis-updated-21

2. https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---27-april-2023

3. https://www.hetero.com/press-release-2022-6

4. https://www.hetero.com/press-release-2022-2

About the Author

Shem Oirere graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy, and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.