- Savara ( NASDAQ: SVRA ) said on Aug. 25 that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) granted promising innovative medicine (PIM) designation to the company's inhaled therapy molgramostim to treat autoimmune pulmonary alveolar proteinosis (aPAP), type of a rare lung disease.
- "This PIM designation was granted on the basis of molgramostim nonclinical and clinical data and further reinforces the potential of molgramostim to provide significant benefit in the treatment of aPAP," said Savara Chair and CEO Matt Pauls.
- The company said the PIM designation is an early indication that molgramostim is a promising candidate for the UK Early Access to Medicines Scheme (EAMS), which provides an opportunity for therapies to be used in U.K. clinical practice in parallel with the later stages of the regulatory process.
- Drugs with a positive scientific opinion could be made available to U.K. patients 12 months to 18 months before formal marketing authorization is granted, Savara added.
- In June, molgramostim was awarded Innovation Passport designation by MHRA and has also received orphan drug designations in the U.S. and EU. and fast track status in the U.S.
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Savara's rare lung disorder drug gets promising innovative medicine status in UK