Company Product Description Indication Status

Anavex Life Sciences Corp., of New York

ANAVEX2-73 (blarcamesine)

Targets sigma-1 and muscarinic receptors

Rett syndrome

FDA granted rare pediatric disease designation

Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J.

Selumetinib

MEK 1/2 inhibitor

Neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas

FDA accepted the NDA with a priority review; PDUFA date in the second quarter of 2020

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis

Empagliflozin

SGLT2 inhibitor

Type 1 diabetes

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 that the benefits of empagliflozin 2.5 mg do not outweigh the risks to support approval as an adjunct to insulin

Healios K.K., of Tokyo, and Athersys Inc., of Cleveland

Multistem (HLCM-051)

Cell therapy

Acute respiratory distress syndrome

Japan's Pharmaceutical Affairs and Food Sanitation Council notified companies that the Ministry of Health, Labour and Welfare will grant orphan regenerative medicine designation within the next few weeks

Zosano Pharma Corp., of Fremont, Calif.

Qtrypta

Formulation of the triptan zolmitriptan

Acute migraine

Completed pre-NDA meetings with the FDA; plans to submit NDA in December 2019

Notes

For more information about individual companies and/or products, see Cortellis.

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