We are pleased to announce that we have now completed our Pivotal BE program for Tafamidis Meglumine Soft Gel Capsules 20mg.
Our product has been developed based on the reference brand Vyndaquel, which is indicated in the treatment of Transthyretin amyloidosis, a highly debilitating orphan disease. This product is currently the only treatment available for this condition, apart from liver transplant procedures. The brand sold approximately $2bn globally in 2021, according to IQVIA.
Based on this positive progress, and due to major technical barriers, we believe we will be one of the few companies capable of bringing this product to the market.
In parallel to this program, we are also working on the development of Vyndaquel 61mg, which is on track in terms of development timelines.
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