Anvisa aprova medicamento para prevenção de enxaqueca
A primeira droga especificamente desenhada para a prevenção de enxaqueca foi aprovada nesta segunda (25) pela Anvisa (Agência Nacional de Vigilância Sanitária). O tratamento deve chegar ao mercado com preço alto, ainda não definido. No Brasil, o medicamento recebeu o nome de Pasurta e será comercializado pela Novartis. Nos EUA a droga leva o nome de Aimovig -fabricada pela Amgen e pela Novartis- e foi aprovada pela FDA (Food and Drug Administration) em maio do ano passado.
O tratamento consiste em uma injeção mensal do medicamento erenumabe, que bloqueia uma proteína, a CGRP, que é relacionada às crises de enxaqueca. Não se trata de uma cura para o problema, mas estudos mostram que em metade dos pacientes que recebem a droga há uma redução de 50% nos dias de cefaleia. Segundo Luis Boechat, diretor médico da Novartis Brasil, 175 mil pacientes já fazem uso da droga.
A doença afeta 1 em cada 7 pessoas no mundo, sendo que 2% da população enfrenta enxaquecas crônicas, ou seja, com crises que ocorrem por 15 ou mais dias por mês. Algumas estimativas apontam que ela é a terceira doença mais comum no mundo, além de ser listada no ranking das dez principais causas de incapacidade. Nos EUA, o medicamento tem um custo anual de cerca de US$ 6.900 por ano (mais de R$ 26 mil pela cotação atual do dólar). Por isso, o tratamento também não deve ser barato no mercado brasileiro.
Após a aprovação da Anvisa, a droga agora espera uma definição de limite de preço por parte da Câmara de Regulação do Mercado de Medicamentos (CMED). A Novartis não fala em possíveis valores. “É uma medicação imunobiológica, de fabricação complexa e manejo complexo, apesar de ser simples de usar. Há de se esperar que venha com um preço diferente de uma medicação sintética”, diz Boechat.
Segundo a farmacêutica, se não houver imprevistos, a droga deve chegar ao mercado entre o final do primeiro semestre e começo do segundo. Segundo Thais Villa, chefe do setor de cefaleia da Unifesp, após a definição de preço será possível ter um detalhamento melhor da indicação. “Só aí poderemos ver o custo-benefício para ser indicado. A indicação provavelmente será para aqueles com enxaquecas mais graves, crônicas e que não responderam aos tratamentos preventivos já conhecidos.”
A Novartis diz que o medicamento pode ser usada por quem tenha quatro ou mais dias de cefaleia por mês. Villa ressalta que, assim como outras medicações para enxaqueca, a droga pode funcionar muito bem -já no primeiro mês de uso-, ter efeito parcial ou até ter um funcionamento abaixo do esperado. Um dos principais pontos positivos da droga, afirma a especialista da Unifesp, são os reduzidos efeitos adversos.
Fonte: Folha Pe
Foto: Arte/Folha de Pernambuco
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