US-based clinical stage pharmaceutical company KalVista Pharmaceuticals Inc (NASDAQ:KALV) announced on Tuesday that it has secured the UK Innovation Passport for sebetralstat, an oral plasma kallikrein inhibitor for treating hereditary angioedema (HAE).
This passport grants access to the UK's Innovative Licensing and Access Pathway (ILAP), expediting market entry and facilitating patient access to new medications.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued the Innovation Passport based on positive phase 3 trial data, which demonstrated the efficacy and safety of sebetralstat.
Delivered in partnership by the MHRA, the National Institute for Health and Care Excellence (NICE), the All Wales Therapeutics and Toxicology Centre (AWTTC) and the Scottish Medicines Consortium (SMC), the Innovation Passport prioritises innovative drugs addressing unmet medical needs.
Sebetralstat, already granted Fast Track and Orphan Drug designations by the US Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency (EMA), is poised for accelerated development and regulatory processes.
WuXi XDC Cayman wins 'Best CDMO' at World ADC Awards 2024
Royalty Pharma acquires RYTELO royalty interest from Geron
Minghui Pharmaceutical announces initial MHB039A Phase I clinical trial results
REGENXBIO reports reduced net loss for nine months to September 2024
Sanofi's Dupixent approved for young children with eosinophilic esophagitis
Research Grid raises USD6.5m seed round
Duoning Biotechnology partners with Branca Bunus on transfection reagents
Intra-Cellular Therapies' CAPLYTA shows promise in preventing schizophrenia relapse
FDA accepts Ionis Pharmaceuticals' donidalorsen New Drug Application
Kazia Therapeutics secures FDA meeting to explore paxalisib pathways for glioblastoma
Neogap Therapeutics partners with NorthX Biologics to enhance cancer cell therapy production
Medivir partners with Eisai to evaluate fostrox in liver cancer
OSE Immunotherapeutics' Lusvertikimab shows promise in ulcerative colitis