Manufacturer Astellas has stopped producing the antibiotic vilprafen worldwide

Pharmaceutical manufacturer Astellas has decided to stop producing the antibiotic vilprafen not only in Russia, but also on the world market, the Japanese company told Kommersant. They clarified that such a step “is determined by the company’s strategy to prioritize efforts and direct investments towards the most innovative approaches to treatment and ensuring their availability in Russia.” Kommersant’s source noted that the issue is a global shortage of the substance. The antibiotic is already difficult to find in pharmacies, but doctors and the Russian Ministry of Health assure: vilprafen has no advantages compared to other macrolide antibiotics. Unless it is only approved for use by pregnant women and during lactation.

The Japanese company Astellas responded to a request from Kommersant about the shortage of the antibiotic vilprafen (international nonproprietary name (INN) “josamycin”). Judging by the search results in the Aptekamos pharmacy aggregator, the drug is not available in any metropolitan pharmacy.

Astellas reported that in 2020 they conducted a global business analysis and decided not only in Russia, but also on the world market to stop producing this antibiotic in all forms: film-coated tablets, 500 mg, suspension 125 mg / 5 ml, 250 mg / 5 ml, 500 mg / 5 ml, as well as vilprafen solutab dispersible tablets 1000 mg. “Patients are always our priority. The adoption of this decision is due to the company’s strategy to prioritize efforts and direct investments towards our most innovative approaches to treatment and ensuring their availability in Russia,” the company said. A Kommersant source familiar with the situation called this step forced – it was caused by a shortage of the substance in the world. According to Astellas, the Russian Ministry of Health was notified of this decision in accordance with Russian law on December 28, 2020 for vilprafen 500 mg film-coated tablets and suspensions, and on March 31, 2023 for vilprafen solutab dispersible tablets. Registration revocation is planned for 2024 and 2026, respectively. “In situations where supplies of vilprafen in Russia are insufficient or unavailable, doctors and patients have a range of alternative treatment options,” Astellas added.

The Ministry of Health, in response to a request from Kommersant, did not report the company’s decision to revoke the registration, but provided data from the “Analytical showcase of the Government of the Russian Federation”, according to which medical organizations are currently provided with drugs with the INN “josamycin” for 6.4 months, and pharmacies – for 0.9 months; for all organizations of the Russian Federation – for 2.6 months. “Despite the fact that in 2023 there is a decrease in the introduction of the drug into civilian circulation, according to data received from the main freelance specialists of the Russian Ministry of Health, this drug can be replaced in therapy with drugs with the INN “azithromycin” and “clarithromycin”, according to which “There is a steady introduction into civil circulation,” the department added. “Currently, the remaining medicinal products with the INN “azithromycin” in civil circulation cover more than a year’s need, and the supply of medicinal products with the INN “clarithromycin” covers an eight-month need.”

RNC Pharma Development Director Nikolay Bespalov confirmed to Kommersant that problems with the supply of vilprafen to the Russian market began in 2021. In ten months of 2023, about 270 thousand packages came into circulation, and in 2022, “decent volumes” were shipped – about 2.3 million packages, and, according to Mr. Bespalov, this was obviously done with an eye to deliveries this year. “But, probably, the available supplies were not enough, now the situation with morbidity is quite tense and, apparently, the demand for the drug turned out to be higher than predicted,” the expert commented. “The drug, in principle, has a lot of replacement options, so there is no tragedy here, the attending physician will select it relatively easily a replacement that is comparable in terms of effectiveness and safety. Although for certain categories of patients this may be a problem – for example, this is one of the few drugs that can be used during pregnancy.” Mr. Bespalov clarified that, according to his information, at least two domestic analogues of vilprafen are being prepared to enter the market.

Infectious disease specialist at the Doctis telemedicine service, Tatyana Kogut, noted that today’s interest in this antibiotic and the increased demand for it may be associated with an increase in the incidence of mycoplasma pneumonia, since macrolide antibiotics are used specifically to treat such infections. “In most cases, there are replacement options; vilprafen has no advantages compared to other macrolide antibiotics, such as azithromycin, clarithromycin,” confirmed Mrs. Kogut. “The only difference is that vilprafen is approved for use by pregnant women and during lactation. Other antibiotics do not explicitly state this, and the decision to prescribe is at the discretion of the physician.”

Natalia Kostarnova