Company

Product

Description

Indication

Status

Alkermes plc, of Dublin, and Biogen Inc., of Cambridge, Mass.

Diroximel fumarate (BIIB-098)

Stimulates the Nrf2 pathway

Relapsing forms of multiple sclerosis

FDA accepted NDA; target action date is in the fourth quarter of 2019

Amicus Therapeutics Inc., of Cranbury, N.J.

AT-GAA

Recombinant human acid alpha-glucosidase plus a pharmacological chaperone

Pompe disease

FDA granted breakthrough designation

Aptose Biosciences Inc., of San Diego

CG-806

FLT3 and BTK kinase inhibitor

Relapsed or refractory B-cell malignancies

Submitted IND application to the FDA

Bausch Health Cos. Inc., of Bridgewater, N.J.

Lotemax SM (loteprednol etabonate)

Corticosteroid

Postoperative inflammation and pain following ocular surgery

FDA approved drug

Diurnal Group plc, of Cardiff, U.K., and Medison Pharma Ltd., of Petach Tikva, Israel

Alkindi (hydrocortisone)

Cortisol hormone granules in capsules for opening

Pediatric adrenal insufficiency

Ministry of Health in Israel validated the MAA; potential approval toward the end of 2019 and launch in Israel in 2020

Eisai Co. Ltd., of Tokyo

Belviq (lorcaserin) and Belviq XR (lorcaserin)

Serotonin 2C receptor agonist

Obesity

FDA accepted sNDA to include data from CAMELLIA-TIMI 61 study of major adverse cardiovascular events 

Taiho Oncology Inc., of Princeton, N.J.

Lonsurf (trifluridine/tipiracil)

Nucleoside analogue and the thymidine phosphorylase

Metastatic gastric or gastroesophageal junction adenocarcinoma

FDA approved drug for treatment of patients previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy

Themis Bioscience GmbH, of Vienna

MV-CHIK

Chikungunya vaccine

Chikungunya prophylaxis

FDA granted fast track designation

Tyme Technologies Inc., of New York

SM-88

Dysfunctional tyrosine derivative

Third-line pancreatic cancer

At a type C meeting with the FDA, the company received feedback on the design of a pivotal trial that will use overall survival as the primary endpoint


Notes

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

 

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