Drug Filing

Mundipharma announces licence extension submission for Invokana and Vokanamet to EMA

As the European distributor of Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM).

GSK submits first regulatory application for daprodustat in Japan

GlaxoSmithKline announced the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anaemia due to chronic kidney disease (CKD).

FDA accepts new drug application for elexacaftor , tezacaftor and ivacaftor combination treatment

Vertex Pharmaceuticals announced the US Food and Drug Administration (FDA) accepted its new drug application (NDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

European Medicines Agency validates marketing application for Filgotinib for the treatment of rheumatoid arthritis

Gilead Sciences and Galapagos announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA).

Stoke Therapeutics granted FDA orphan drug designation for STK-001 for Dravet Syndrome

Stoke Therapeutics, a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.

Alnylam’s givosiran gets FDA priority review for acute hepatic porphyria

Alnylam Pharmaceuticals’ investigational RNAi therapeutic givosiran has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of acute hepatic porphyria (AHP).

ViiV Healthcare submits regulatory application to EMA for investigational Cabotegravir to be used in combination with Rilpivirine for HIV

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

NeuroVive’s NeuroSTAT Project receives FDA fast track designation

NeuroVive Pharmaceutical AB announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.

Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat to treat epithelioid sarcoma

Epizyme announced that the US Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.