CHMP recommendation for Feraccru (ferric maltol) to treat iron deficiency anaemia in patients with inflammatory bowel disease- Shield Therapeutics

Shield Therapeutics plc announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the investigational drug Feraccru (ferric maltol) capsules, a twice daily oral therapy. The data submitted in the MAA support the use of Feraccru in the treatment of adults with iron deficiency anaemia in patients with inflammatory bowel disease (IBD).

The CHMP’s recommendation will now be reviewed and ratified by the European Commission, which has the authority to approve medicines for use in the twenty-eight countries of the European Union. The company currently anticipates the product will become available on a commercial basis during the first half of 2016.

This positive opinion is based on data from the company’s prospective, randomised, placebo controlled “AEGIS” clinical programme (AEGIS-1 and AEGIS-2) that enrolled adult patients with anaemia secondary to inflammatory bowel disease and for whom treatment with oral ferrous products was unsuccessful. Statistically significant improvements in haemoglobin (Hb) were observed, vs. placebo, after 12 weeks of treatment with oral Feraccru (ferric maltol) capsules (30 mg twice a day) [2.25 (0.19) g/dL ]. Hb improvements [3.07 ±1.46 g/dL] continued to be seen throughout the open-label safety phase, which followed patients for up to a total exposure of 64 weeks. Normalisation of Hb was achieved in two-thirds of patients after 12 weeks of treatment and in more than or equal to 80% of patients who continued treatment for up to 64 weeks. The safety profile of ferric maltol was comparable to placebo at 12 weeks and well tolerated in treatment up to 64 weeks, with 75% of entered patients completing the long-term phase. Throughout the 64-week study period, median compliance to the prescribed therapeutic regimen was 97%.