FDA: 25 new drugs
between January and June
At the halfway point of this year (January to end of June), the FDA has approved 25 new drugs and biological products. That is well above the 18 new arrivals given a greenlight in 2019. But the impact of the Covid-19 pandemic is likely to become more and more evident in the coming months, with delays on several decisions, despite advisory committees going virtual.
Among all the fields of R&D, the first-to-market approval tally shows the approval of the first drug used to help image tau pathology, a distinctive characteristic of Alzheimer's disease. Tauvid (flortaucipir F18) is an intravenous injection manufacturerd by Avid Radiopharmaceuticals, Inc.
In April, the FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking Trodelvy. The treatment is manufactured by Immunomedics, Inc.
Several approvals were also granted in lung cancer (Zepzelca in metastatic small cell lung cancer; Retevmo in lung and thyroid cancers; Tabrecta in non small cell lung cancers) or to treat migraine (Vyepti and Nurtec OTD).
In the meantime, the FDA worked on guidance for the development of of vaccines to prevent the COVID-19. As an exemple, for a vaccine that would be widely deployed against COVID-19, the FDA said its expected sponsors to demonstrate that the vaccine is at least 50 % effective in a placebo-controlled trial. Merely showing immune response data would not be enough for a vaccine candidate to obtain an approval.