The drug Lagevrio with the active ingredient molnupiravir may no longer be prescribed: the EMA rejected the application for approval of the preparation for the treatment of Covid-19. A clinical benefit for patients could not be determined. Spicy: Governments such as those of Germany and Austria had already procured the drug without approval at the beginning of 2022 and placed it on the market despite warnings of dangerous side effects.
On February 24, the EMA rejected the manufacturer MSD / Merck’s application for approval of Lagevrio. The pharma giant failed to show that the drug reduced the risk of hospitalizations and deaths. The duration of the illness was also not shortened. According to EMA’s Competent Committee, it was impossible to identify a specific group of patients in the EU in whom a clinically relevant benefit of Lagevrio could be expected. The benefit-risk ratio in the treatment of Covid-19 could therefore not be determined.
In several EU countries, however, the governments had relied on the first interim results of the manufacturer studies, procured the drug centrally and had it given to Covid risk patients without approval. “The Federal Ministry of Health (BMG) has been marketing the centrally procured drug Lagevrio on the basis of the MedBVSV without approval since the beginning of 2022. The basis for this was an assessment by the BfArM on the expected positive benefit-risk ratio. Meanwhile, the central approval process was ongoing,” the German Federal Institute for Drugs and Medical Devices (BfArM) explained in a letter. Now that the procedure is complete, further dispensing of the drug is discontinued. Goods that have already been delivered to pharmaceutical wholesalers and pharmacies may no longer be handed in.
The Austrian Federal Ministry for Social Affairs, Health, Care and Consumer Protection justifies its use in a press release as follows: “Lagevrio was used in many EU countries to protect people from serious illnesses. Clinical studies initially showed that Lagevrio was effective. Therefore, the Ministry of Health decided to purchase the drug and use it within the compassionate use program.” Around 25,000 packs of Lagevrio are said to have been administered; another 100,000 packs are still in stock. In individual cases, treating physicians can still use the drug “after an individual benefit-risk assessment as part of a so-called healing attempt (named patient use)”. Since even the EMA, which is otherwise so enthusiastic about approval, sees no benefit in the preparation, this can probably be regarded as questionable. As early as the beginning of 2022, experts warned of significant risks and side effects from the use of molnupiravir and linked it to genetic mutations and malformations.
The Lagevrio case shows once again how delusional governments stocked up on questionable drugs at the expense of taxpayers during the “pandemic” without even beginning to question their risks and benefits. The conclusions that the EMA has now drawn with regard to Lagevrio could honestly also be drawn with regard to the Covid vaccines. However: All the obviously critical aspects of the manufacturers’ approval studies were consistently ignored here by the EMA. Demands on Pfizer and Co. to finally disclose all data are still in vain.