Press Release20 Apr 2024, 08:54 pm
Zydus Lifesciences' Subsidiary Receives UK Marketing Authorization for NULIBRY® for MoCD Type A Treatment
AI Summary
Zydus Lifesciences' subsidiary, Sentynl Therapeutics, has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for NULIBRY® (fosdenopterin) for Injection, marking it as the first therapy for MoCD Type A in the UK. This genetic disorder, which affects fewer than 150 patients globally, has a median survival age of four years. NULIBRY ® has demonstrated safety and efficacy in clinical trials, showing that NULIBRY-treated patients had a 5.5 times lower risk of death than that of untreated patients.
Key Highlights
- Zydus Lifesciences' subsidiary, Sentynl Therapeutics, receives UK marketing authorization for NULIBRY® (fosdenopterin) for MoCD Type A treatment
- NULIBRY ® is the first and only approved therapy in GB for MoCD Type A
- MoCD Type A is an ultra-rare, life-threatening genetic disorder with a median survival age of four years
- NULIBRY ®'s approval supported by data from three clinical trials showing a 5.5 times lower risk of death for NULIBRY-treated patients compared to untreated
- This approval advances Sentynl's mission to make a positive impact in the lives of patients suffering from rare diseases