U.S. Regulatory News February 2018

Aclaris Therapeutics Inc.

Genentech

FDA approved Avastin for the treatment of adults with glioblastoma that progressed following prior therapy.

GlaxoSmithKline

FDA approved expanded use of Nucala for the treatment adult patients with eosinophilic granulomatosis with polyangiitis.

FDA approved Xepi cream for the treatment of impetigo in patients two months of age and older.

MeiraGTx

AAV2/5-OPTIRPE65

FDA granted rare pediatric disease designation for the treatment of certain patients with Leber congenital amaurosis.

Novo Nordisk A/S

Ozempic

FDA approved Ozempic for the treatment of diabetes.

FDA granted orphan drug designation for the treatment of Dravet syndrome, a severe and rare form of childhood epilepsy that typically presents during the first year of life.

Xeljanz

FDA approved two different dosages of Xeljanz for patients with active psoriatic arthritis who have not responded to other treatments.

Polaryx Therapeutics

PLX-100

FDA granted orphan drug designation for the treatment of neuronal ceroid lipofuscinosis.

Admelog

FDA approved Admelog as a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

Seres Therapeutics Inc.

FDA granted orphan drug designation for the treatment of ulcerative colitis in pediatric patients.

FDA granted orphan drug designation for the treatment of congenital adrenal hyperplasia.

PD-protec

FDA granted orphan drug designation for peritoneal dialysis fluid for the treatment of patients with end-stage renal disease (kidney failure).

FDA gave supplemental approval of Tylovet Soluble for the addition of the following indication for use in chickens: “For control of mortality caused by NE associated with Clostridium perfringens in broiler chickens.”

FDA gave supplemental approval to Lincomix 20 and Liincomix 50 to modernize the language of the previously approved indication, “for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae” to read “for reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae”; and adds a range of approved feed inclusion rates to provide for the use of lincomycin at 100 to 200 grams per ton of complete feed, fed as the sole ration for 21 consecutive days, for reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae.

FDA gave supplemental approval for Telazol for intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic.