Savara gains PIM designation for molgramostim in the UK

Texas, USA-based clinical-stage biopharma Savara (Nasdaq: SVRA) says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation to molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease with no approved pharmaceutical treatments. News of the development pushed Savara’s shares up as much as 2.5% to $1.61.

PIM designation is an early indication that molgramostim is a promising candidate for the EAMS, a program that provides an opportunity for important therapies to be used in UK clinical practice in parallel with the later stages of the regulatory process. Medicines with a positive scientific opinion could be made available to UK patients 12-18 months before formal marketing authorization is granted.

On June 15, 2022, molgramostim - which has the trade name Molgradex - was awarded Innovation Passport designation by the MHRA. In 2019, molgramostim was granted Fast Track Designation and Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for the treatment of aPAP, and in 2012 and 2013 was granted Orphan Drug designation for the treatment of aPAP in the USA and European Union, respectively.