EMA committee recommends approving Rasonque for pancreatic cancer treatment — Cyprus Mail
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization for Revolution Medicines’ oral drug Rasonque for the treatment of pancreatic cancer. As Cyprus Mail reports, the recommendation still needs to be reviewed by the European Commission.
The drug, whose chemical name is daraxonrasib, received accelerated approval in the United States in August following the U.S. Food and Drug Administration’s accelerated review procedure. Analysts forecast that Rasonque’s peak global annual sales could reach $11.5 billion.
Market entry plans
Revolution Medicines is preparing for a broad commercial launch of the drug in Europe without a local sales partner. The California-based company said it is building regulatory, medical and commercial infrastructure, as well as market access structures, in several key European countries.
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Revolution Medicines CEO Mark Goldsmith previously said that the company aims to make the drug available as widely as possible worldwide, although the process differs by country. Three Wall Street analysts believe the company can manage an independent entry into the European market, despite this being its first approved drug.
Funding and hiring
Revolution Medicines’ agreement with Royalty Pharma provides for up to $2 billion in funding for the drug’s development and marketing. Analysts believe this has reduced investors’ expectations that the company would need to seek a partner for commercialization outside the United States.
According to LinkedIn, over the past month the company has posted at least 50 job openings in the United Kingdom and European countries, including Germany, Italy, France and the Netherlands. The positions are related to commercial activities and regulatory expertise. Stifel analyst Laura Prendergast expects peak sales of the drug outside the United States, mainly in Europe and Japan, to amount to between $3.2 billion and $3.3 billion.
