“No Clear Benefit” – Approval rejected: Out for Covid drug

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The European Medicines Agency (EMA) has rejected the application for approval of Lagevrio (active substance molnupiravir) for the treatment of Covid-19 on the basis of new data. This also affects 100,000 packs in Austria. However, the Ministry of Health is trying to calm people down: there are still plenty of other corona medicines available, they emphasize.

There is “no longer a clear benefit for patients with the prevailing virus variants and the current immunization situation in the population,” the health ministry reported. The administration will therefore also be discontinued in Austria.

25,000 packs administered so far
Lagevrio was used in many EU countries to protect people from serious illnesses. Clinical studies had initially shown good effectiveness. So far, about 25,000 packs have been administered in Austria and about 100,000 packs are still in stock.

“Covid medicines are saving lives. That is why we have decided to purchase various preparations as early as possible. We still have enough alternative preparations that members of risk groups can use to protect themselves against a serious illness,” said Health Minister Johannes Rauch (Greens) on Monday.

It is still possible to take it in individual cases
The Ministry of Health has now withdrawn the drug from the “compassionate use program”, under which it was previously given to high-risk patients. They are used to rapidly make medicines available for the treatment of emerging diseases under strictly controlled conditions.

However, in individual cases, doctors may continue to prescribe Lagevrio after an individual benefit-risk assessment as part of a so-called treatment attempt (named patient use).

Source: Krone

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