FDA Grants Fast Track Designation to Polycythemia Vera Treatment

MEEFRO September 22, 2023

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The drug, 9MW3011, is also approved for clinical study by NMPA.

Mabwell announced that its polycythemia vera treatment has been granted fast track designation by FDA.

The designation expedites the review process and can help get valuable new treatments to patients at a faster pace.

In a press release, Mabwell noted that 9MW3011 has also been approved for clinical study in China by NMPA, and the first patient to receive a dose in a clinical study occurred in March, 2023.

The drug inhibits the absorption and release of iron, lower sodium levels, and can upregulate the level of hepcidin expressed by hepatocytes.

Source

(Sept. 22, 2023); Mabwell; FDA Grants Fast Track Designation to 9MW3011; https://mabwell.com/en/news_info/id-116.html