- The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) granted an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) to Avrobio's ( NASDAQ: AVRO ) gene therapy AVR-RD-02 to treat Gaucher disease.
- The Innovation Passport is the first step in the ILAP process for regulatory and development milestones with the aim of early patient access in the U.K., the company said in a statement on Tuesday.
- Avrobio's noted that AVR-RD-02 has previously received fast track status in the U.S. and orphan drug designations in the U.S. and EU.
- Gaucher disease is a rare lysosomal disorder caused by buildup of certain fatty substances in organs, mainly the in the spleen and liver.
- AVRO +8.65% to $0.66 premarket Oct. 18
For further details see:
Avrobio rises as gene therapy for Gaucher disease gets ILAP designation in UK