AstraZeneca's diabetes drug granted fast track designation for heart failure; Verrica sends skin infection treatment to FDA
→ A couple weeks after announcing that their diabetes drug cut the risk of CV death or worsening of heart failure by 26% in a landmark study, AstraZeneca announced that the FDA has granted fast track designation for Farxiga in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The drug was given the same designation last month for renal failure and the prevention of renal death and CV in patients with chronic kidney disease.
→ Dermatology-focused Verrica Pharmaceuticals $VRCA has submitted an NDA for their topical therapy, VP-102, for the treatment of molluscum contagiosum — a highly contagious viral skin infection that affects approximately 6 million people, primarily children, in the United States. Back in June, the company released positive results of the drug from its COVE-1 Phase II study for the treatment of verruca vulgaris, or common warts.
→ Wave Life Sciences $WVE — which entered into a meaty partnership with Takeda last year — has secured fast track status from the FDA for its Duchenne drug, which is engineered to directly compete with Sarepta‘s pioneering Exondys 51. The therapy, called suvodirsen, is currently being tested in a Phase II/III study, and Wave is gearing up for regulatory submissions in the second half of next year.
→ Anavex broke out some preliminary data from a mid-stage trial involving patients with Rett syndrome, a genetic brain disorder that occurs almost exclusively in girls. Patients in the trial were either given a 5 mg daily oral liquid dose of the experimental drug, blarcamesine, or placebo. The company $AVXL disclosed that in six patients who were given the drug, there were improvements in two secondary endpoints — the Rett Syndrome Behaviour Questionnaire and the Clinical Global Impression — after seven weeks of treatment.
→ GlaxoSmithKline has won an expanded FDA approval for Nucala, extending its reach to a young patient population. The IL-5 drug, which was first approved in 2015, can now be used to treat children as young as 6 with severe eosinophilic asthma.