FDA new drug approvals in Q2 2018

The second quarter of 2018 saw an uptick in drug approvals as 15 new drugs received a green light from the FDA (TABLE 1), compared with 6 in the first quarter. Among the most notable of the new crop was GW Pharmaceuticals’ cannabidiol (Epidiolex), the first cannabis-derived drug to gain FDA approval. Epidiolex was cleared to treat two very rare types of severe childhood epilepsy, Lennox–Gastaut syndrome and Dravet syndrome, and is forecast to reach blockbuster sales of US$2.35 billion by 2024. However, it is hard to know how much of a threat over-the-counter cannabinoid-based oils present to products such as Epidiolex, and forecasts could be revised…

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Fonte: 536 | AUGUST 2018 | VOLUME 17 www.nature.com/nrd