Want to dig deeper into the decision by the US Food and Drug Administration to grant priority review for Co-Artem, the incredibly effective anti-malaria drug from Novartis. Will that allow the Swiss pharmaceutical company to expand its global market share--and if so, by how much?
It's obvious Novartis is NOT looking for a big boost from the US domestic market since only 1200 people (most of them returning travellers) are treated for malaria in the US each year.
Co-Artem is already available in countries covered by the US President's Malaria Initiative, primarily through multi-million dollar contracts with UNICEF. And there's plenty more flowing through Global Fund contracts.
So what is the advantage of going for FDA approval? I am not suggesting anything nefarious. I saw Co-Artem save lives firsthand while I was in Malawi the past three months. I just want to understand the business case.
NB: For a great article explaining how difficult it is to estimate how many people suffer from from malaria each year, check out Laura Blue's piece at TIME.com.
Developing country drug registration systems are a mess, and so FDA approval can often speed up the process. It also makes it easier to receive approval for funding from the Global Fund and other international donors, although I can't imagine that's been a particularly large hurdle for Coartem.
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