Drug Profile
Adrulipase alfa - First Wave BioPharma/Mayoly-Spindler
Alternative Names: Adrulipase; MS-1819; MS1819-SD; Recombinant lipase - First Wave BioPharma/Mayoly-SpindlerLatest Information Update: 19 Jul 2023
Price :
$50
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At a glance
- Originator Mayoly-Spindler
- Developer First Wave BioPharma; Mayoly-Spindler
- Class Anti-inflammatories; Carboxylic ester hydrolases; Pancreatic enzymes; Recombinant proteins
- Mechanism of Action Lipase replacements
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase II Exocrine pancreatic insufficiency; Pancreatitis
Most Recent Events
- 13 Jul 2023 First Wave Biopharma plans to conduct the end-of-phase II meeting with the US FDA in the fourth quarter of 2023
- 13 Jul 2023 First Wave BioPharma announces intention to submit BLA to US FDA for Exocrine pancreatic insufficiency
- 28 Jun 2023 First Wave Biopharma completes a phase II SPAN clinical trials in Exocrine pancreatic insufficiency in USA (PO) (NCT05719311)