AUTL - Autolus Therapeutics' AUTO4 nabs accelerated approval in U.K. for T Cell Lymphomas
Autolus Therapeutics (AUTL) has received innovative licensing and access pathway ((ILAP)) designation from the U.K. Medicines and Healthcare products Regulatory Agency ((MHRA)) for AUTO4 being studied in a Phase 1 study in TRBC1 positive Peripheral T Cell Lymphoma ((PTCL)). ILAP was launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development.Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application assessment, rolling review and a continuous benefit risk assessment.“The granting of the Innovation Passport and entry into ILAP comes soon after we received PRIority MEdicines ((PRIME)) designation from the European Medicines Agency for AUTO1,” said Dr. Christian Itin, Chairman and CEO.
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Autolus Therapeutics' AUTO4 nabs accelerated approval in U.K. for T Cell Lymphomas