Sanofi’s Kevzara shortage looms as Actemra scarcity spills over

FRANCE – Actemra from Roche has been in high demand since its efficacy in treating severe COVID-19 was established, resulting in shortages. Sanofi’s rival therapy Kevzara has now been impacted by supply constraints as well.

According to Sanofi, based on current demand, supply of all four Kevzara (sarilumab) formats – 150 mg or 200 mg pre-filled syringes or auto-injectors – will be limited until early 2022.

Roche’s arthritis medication Actemra has quickly risen to the forefront of the pandemic fight for critically ill COVID-19 patients.

In August, Roche’s Genentech division announced that it was experiencing unprecedented demand for Actemra (tocilizumab) – known as RoActemra in some markets – due to the spread of the highly transmissible delta variant of SARS-CoV-2.

Actemra, was granted emergency approval in June for hospitalized patients 2 years of age and older who are receiving systemic corticosteroids and require respiratory support after it was shown in a clinical trial to reduce mortality.

Shortly after, there were widespread reports of patients with rheumatoid arthritis and other inflammatory diseases who were on Actemra’s label having difficulty accessing their treatment.

However, with the spotlight has come “unprecedented” demand, and the drugmaker is struggling to keep up pace.

As supplies became scarce, the National Institutes of Health (NIH) advised using Kevzara instead of Actemra because the two drugs work in the same way, inhibiting the IL-6 receptor and preventing the runaway immune response that can lead to life-threatening outcomes in severe COVID-19.

Since Chinese doctors first proposed the treatment regimen comprising of anti-IL-6 and corticosteroids early last year, doctors have been using it in hospitalized patients.

The recommendation was made by the US agency despite the fact that Kevzara is not approved or authorized for emergency use in the treatment of COVID-19 anywhere in the world.

Kevzara failed trials in COVID-19-treated patients who were severely or critically ill. However, Sanofi said it is “working diligently to manage supply to minimize the impact of this increase in demand,” and will “continue to prioritize access for indicated patients with rheumatoid arthritis.”

The National Institutes of Health’s COVID-19 Treatment Guidelines Panel recently recommended the id use IV Kevzara (sarilumab) as an alternative to IV tocilizumab “only when IV tocilizumab is not available or not feasible to use” may help alleviate the shortage of tocilizumab in hospitals.

In August, the World Health Organization (WHO) urged Roche to license the technology required to manufacture Actemra to other manufacturers as soon as possible so that production capacity could be ramped up.

Actemra sales increased 32 percent to US$3.12 billion in 2020 as a result of the pandemic boost. According to a Roche half-year report, the drug has already earned CHF 1.64 billion (US$1.79 billion) in 2021, a 17 percent increase over the same period the previous year.

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