The drug Adakveo (crizanlizumab) had its registration sought by the National Health Surveillance Agency (Anvisa). In a note, the inspection body informs that the registration was canceled because there were flaws in proving the product's effectiveness. Its use is to reduce the frequency of vaso-occlusive crises in patients diagnosed with sickle cell disease.
“The failure was observed in monitoring the Term of Commitment, signed between the company and Anvisa at the time of granting the health registration. The decision took into account both the analysis of the technical documentation presented, as well as meetings with the company and consultation with the Brazilian Association of Hematology, Hemotherapy and Cellular Therapy”, reinforces the note.
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The report also provides more details about the ban, highlighting that, similarly, the Committee for Medicinal Products for Human Use of the European Medicines Agency, also concluded that the benefits of crizanlizumab are not greater than the risks presented. Given this scenario, it also recommended the revocation of Adakveo's conditional marketing authorization.
Finally, it is worth remembering that in August, the European Commission also revoked the sale of the medicine throughout the European Union.
For patients who use the medicine provided free of charge by the manufacturer, Anvisa informs that the decision to continue the treatment or not is the responsibility of the doctors. Furthermore, the patient's consent must be obtained.
In short, compassionate use and expanded access assistance programs are regulated by Anvisa. Therefore, they allow the free supply of medicine, even if it is still in the clinical study phase.
In these cases, companies sponsor the treatment of patients. However, the condition must be serious debilitating or life-threatening illnesses. Furthermore, there cannot be any treatment alternative with already registered products.
Finally, in this sense, the note informs that “cancellation of registration does not prevent the company from obtaining data favorable clinical findings that prove the effectiveness, file the registration request again for a new technical evaluation of the Anvisa”.