As the first half of 2020 looks set to end on an encouraging note for new drug approvals despite the ongoing coronavirus pandemic, we take a look at news stories that made headlines on the regulatory front this month.
A new therapy by the name Uplizna, developed by Viela Bio (VIE), received FDA approval on June 11, for the treatment of neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Uplizna is only the second approved treatment for the disorder, the other being Alexion's Soliris.
On June 16, Novartis' Ilaris, the first treatment for adult-onset Still's disease, a severe and rare inflammatory disorder, secured the FDA stamp of approval.
Another first that merits mention is the FDA approval of Ultragenyx Pharmaceutical Inc.'s (RARE) Crysvita for the indication of tumor-induced osteomalacia, the first therapy for a rare disease that causes low phosphate blood levels and bone softening.
As of this writing, 24 novel drugs have received FDA approval so far this year compared to just 13 during the same period last year. For the full year of 2019, forty-eight novel drugs made it to the finish line.
Let's take a look at the biotech stocks facing FDA decision in July.
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