Sanofi announced on Friday that it will donate 100 million doses of Plaquenil (hydroxychloroquine) to 50 countries and has begun to deliver the drug to authorities that have requested it. CEO Paul Hudson remarked that "it is critical that international authorities, local governments, manufacturers, and all the other players involved in the hydroxychloroquine chain work together in a coordinated manner to ensure all patients who may benefit from this potential treatment can access it. If the trials prove positive, we hope our donation will play a critical role for patients."
In response to growing number of requests for hydroxychloroquine, Sanofi said it doubled its incremental production capacity across its eight hydroxychloroquine manufacturing sites and is on track to quadruple production by the summer.
Further, Sanofi noted that it plans to assist as many countries as possible, starting with those where its drug is registered for current approved indications along with countries where there are no hydroxychloroquine suppliers or with underserved populations. Sanofi added that it will ensure continued supply of the drug for patients treated under the current approved indications of the medicine, notably including lupus and rheumatoid arthritis.
However, Sanofi noted that "to date, there is insufficient clinical evidence to draw any conclusion over the safety and efficacy of hydroxychloroquine in the management of COVID-19 patients". The drugmaker said that it will continue to donate hydroxychloroquine to governments and hospital institutions if ongoing clinical trials demonstrate its efficacy and safety in COVID-19 patients.
Bayer, Novartis and Teva have recently announced donations of chloroquine and hydroxychloroquine as part of global efforts exploring use of the medicines to treat patients with COVID-19 infection. Meanwhile the FDA has issued an emergency-use authorisation to the Biomedical Advanced Research and Development Authority to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be used to treat hospitalised patients with COVID-19, when a clinical trial is not available or feasible.
Last month, Sanofi and Regeneron Pharmaceuticals announced that they have initiated a clinical programme evaluating whether IL-6 inhibition with Kevzara (sarilumab) is better than current supportive care alone for patients hospitalised with severe COVID-19.
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