Alkermes sent reeling as FDA refuses review of depression treatment
pharmafile | April 3, 2018 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Alkermes, FDA, depression, major depressive disorder, pharma
Alkermes shares were knocked down to their lowest level since October 2016 after it was revealed that the FDA had refused to review its major depressive disorder (MDD) treatment ALKS 5461 due to concerns the company provided insufficient evidence to adequately determine its efficacy.
Alkermes confirmed that it had received a ‘Refusal to file’ letter from the US regulator, with Chief Executive Officer Richard Pops noting in a conference call that the company was, “based on our previous interactions with the agency, surprised” at the FDA’s decision.
While Alkermes has hyped ALKS 5461 as somewhat of a potential blockbuster, the drug, which is designed to treat MDD in patients who have proved unresponsive to other therapies, previously failed in two Phase 3 trials before the manufacturer found more success in a third, refined study, meaning its rejection should not be such a big surprise.
While the FDA has not specified exactly what extra data is necessary, it did highlight the need for “additional well-controlled clinical trials” in order to review the drug’s effectiveness – something which could be an expensive pursuit for the Irish firm. While a Phase 3b study is ongoing, it is uncertain whether the data it generates would satisfy the outstanding requirements from the US agency, as it was never designed to be used to back up an approval.
In an official statement, Pops said: “We are extremely disappointed with this decision and the implications for patients in the US suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families. We strongly believe that the clinical development programme, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favourable benefit-risk profile.”
Matt Fellows
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