Novartis: blood drug gets FDA 'breakthrough' status

(CercleFinance.com) - Swiss biopharmaceutical company Novartis said on Tuesday that US regulators have given "breakthrough" therapy status to an investigational drug preventing vaso-occlusive crises in sickle cell disease.


According to FDA guidelines, treatments that receive "breakthrough therapy" designation treat serious and life-threatening diseases, and deserve fast-track development and approval.

Novartis said that the FDA's decision was supported by phase II results, which showed crizanlizumab reduced sickle cell pain crises.

Novartis also said that its Sandoz division has now launched, alongside partner Pear Therapeutics, its prescription digital therapeutic for patients with opioid use dsorder.

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