Novo Nordisk NVO announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of Alhemo (concizumab) as the first once-daily subcutaneous prophylactic treatment for patients aged 12 years or older living with haemophilia A or B with inhibitors.

Novo Nordisk’s Alhemo is a monoclonal antibody that blocks the TFPI, a protein that prevents blood clotting. By inhibiting TFPI, Alhemo promotes thrombin production, aiding blood clotting and stopping bleeding even in the absence/deficiency of other clotting factors. This enables Alhemo to promote clot formation even in the presence of inhibitors.

The drug is already approved in Australia and Switzerland for treating adolescents and adults (12 years and older) with hemophilia A or B with inhibitors. NVO also markets Alhemo in Japan to treat the same patient population (with and without inhibitors) and is used for routine prophylaxis to reduce or prevent bleeding episodes.

Year to date, shares of Novo Nordisk have gained 14.2% compared with the industry’s 20.6% growth.

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Basis of the Positive CHMP Opinion for NVO’s Alhemo

Per Novo Nordisk, the positive CHMP opinion recommending the approval of Alhemo in the EU is based on results from the phase III explorer7 study, which assessed the efficacy and safety of Alhemo for patients with hemophilia A or B with inhibitors. Subject to approval, Alhemo will come in a portable, pre-mixed, prefilled pen, allowing for quick and convenient subcutaneous administration and reducing the need for regular intravenous infusions, which will greatly reduce the treatment burden for patients and improve quality of life. Currently, patients living with haemophilia B with inhibitors have very limited treatment options.

Hemophilia is a rare bleeding disorder that hinders the body's ability to form blood clots. It is commonly treated with replacement therapy, which involves intravenous infusions of the missing clotting factor. However, some patients develop inhibitors, an immune response that renders replacement therapy ineffective and limits treatment options, representing a high unmet medical need. NVO believes that around 30% of patients with severe hemophilia A and 5-10% of those with severe hemophilia B develop these inhibitors.

Novo Nordisk expects a final decision from the European Commission within the next two months.

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