Spectrum withdrew the BLA for eflapegrastim in March 2019 to provide more information to the FDA on the chemistry, manufacturing and controls process. The FDA accepted the BLA for eflapegrastim for the management of chemotherapy-induced neutropenia in December 2019 and set a PDUFA date of 10/24/2020.
The FDA followed the recommendation of the advisory committee and rejected vernakalant due to safety concerns. The FDA requested a trial to assess the cardiovascular risk and that Correvio develop a process to identify patients at low risk of adverse cardiovascular adverse events.
Melinta Therapeutics filed for bankruptcy in December 2019. Melinta is developing solithromycin, a drug for macrolide resistant bacteria. The FDA rejected solithromycin in December 2016.
Urovant submitted an NDA for vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Announced Research Updates
Orphazyme announced that in an open-label extension of the Niemann-Pick disease trial, 41 patents completed an additional 12-months of treatment. Patients switched from placebo to arimoclomol saw a reduction in NPC-CSS, while patients that continued on arimoclomol had a progression in NPC-CSS, primarily from patients < 4 with aggressive disease.
Incyte announced that in a 28-day, 439 patient, Phase III trial, treatment with itacitinib and corticosteroids did not improve overall response rate compared to placebo (74% vs 66%) in patients with treatment-naive acute graft-versus-host disease.
Published Research Updates
A meta analysis of serelaxin heart failure trials concluded that while serelaxin reduced the risk of 5-day worsening heart failure and changes in renal function markers, it did not decrease length of stay, cardiovascular death, heart or renal failure.
In the 72-week, 318 patient, Phase IIb, ENCORE-NF trial, emricasan did not improve the CRN fibrosis stage without suffering a worsening of steatohepatitis compared to placebo in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis.
In a 3-year, 15 patient, Phase I/II, open-label trial, treatment with valoctocogene roxaparvovec eliminated annualized treated bleeding events and factor VIII infusions in patients with hemophilia A.
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