Week's news analysis

FDA: 25 new drugs
between January and June

By The Editor - 09 July 2020

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.

Development and Licensure of Vaccines to Prevent COVID-19
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

According to FDA Commissioner Stephen Hahn, it is still impossible to predict when a coronavirus vaccine will be available after US President, Donald Trump, declared a vaccine or therapeutic would be ready "long before the end of the year". So far, the FDA is overseeing 141 clinical trials of potential COVID-19 treatments (vaccines, drugs...)

First step in the battle against the disease: beginning of May, the FDA issued an emergency use authorization for the Gilead's drug remdesivir. The drug appears to reduce the amount of time an hospitalized patient takes to recover from the coronavirus, but its does not cure the infection.

Gilead ramps up its Covid-19 strategy with Remdesivir| Read...
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