Note on drug Raptiva
This article was translated by an automatic translation system, and was therefore not reviewed by people.
Regarding the news about the withdrawal of the drug Raptiva of the U.S. market to Anvisa states that:
1. The Agency is monitoring the events and are taking all appropriate steps towards the reassessment of the risk-benefit profile of the drug Raptiva ® [efalizumabe];
2. The product in question has registered indication for severe psoriasis in plaque, in refractory patients and candidates for systemic therapy;
3. The Anvisa had banned the import license of the product in order to give time to making a final decision by the Agency and at the same time safeguard the Brazilian patients who use the product;
4. The reason for the cancellation requested by the company in the U.S. there is the occurrence of three cases of PML (progressive multifocal leucoencephalopathy), serious and debilitating disease of the central nervous system.
5. The Anvisa believes that many patients may be benefit from treatment with efalizumabe, but the lack of predictive factors for the development of adverse event in question and the seriousness and lack of treatment for this result, lead us to conclude that cancellation of registration even with no reports of PML in Brazil.
Source: Anvisa
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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