Regulator approves emergency use of MSD’s Covid-19 pill

SA’s medicines regulator has granted pharmaceutical manufacturer MSD emergency authorisation to import its coronavirus pill molnupiravir, the first treatment that high-risk patients can potentially take at home.        

But it is not clear how widely it will be used, as the health department has no plans to order it for state patients, a top official told Business Day on Thursday. 

Molnupiravir was initially hailed as a possible game-changer as all other treatments now available in SA require intravenous administration and must be used in hospital.

But a review commissioned by the health department advised against using it. While the drug provided a modest reduction in the risk of hospital admissions and death from Covid-19 in high-risk patients, having to use it within five days of symptom onset limited its feasibility.

“We are not going to procure (it) for the public sector. The evaluation showed that it is not significantly better than how we treat Covid now,” said health department deputy director-general Nicholas Crisp.

The health department’s decision was not surprising, as the efficacy of molnupiravir was controversial and the disease had to be diagnosed early for the drugs to work, said Francois Venter, director of the Ezintsha centre at Wits.

The South African Health Products Regulatory Authority (Sahpra) has given MSD permission to import 8-million capsules over the next six months, enough to treat 200,000 patients, according to CEO Boitumelo Semete. Unlike Sahpra’s previous emergency use authorisations for Covid-19 vaccines, which restricted sale to the national health department, its compassionate use approval of molnupiravir allows it to be sold in both the public and private sectors, she said.

Sahpra’s authorisation includes the condition that molnupiravir should not be used during pregnancy, and women of child-bearing age should use contraception during treatment and for four days after they take the last pill. Treatment consists of 40 pills taken over five days.

Sahpra is conducting a rolling review of MSD’s application for full market registration of molnupiravir, and has received one registration application from a generic manufacturer, said Semete, declining to name the applicant. MSD has agreed to issue voluntary licences to more than two dozen generic manufacturers around the world under a deal negotiated by the UN-backed Medicines Patent Pool. SA is among the MPP’s eligible countries, but the deal it struck with MSD limits the sale of generic molnupiravir to the public sector.

It is not clear at this stage what molnupiravir will cost in SA. Semete declined to comment on pricing, saying the regulator’s role was restricted to ensuring the products it authorises are safe, effective and of good quality.

A course of molnupiravir obtained via the MPP deal is expected to cost about $20 in poorer nations, according to Reuters, markedly less than the $700 per course the US agreed to pay for an initial delivery of 1.7-million courses.

kahnt@businesslive.co.za