Novo Nordisk's ($NVO) obesity therapy Saxenda is on a roll. Just over a month after snagging FDA approval, the drug scored a positive recommendation on Thursday from Europe's Committee for Medicinal Products for Human Use (CHMP). But by the time it gets to the regulatory finish line, the med may have some competition on the continent.
With its CHMP nod in hand, the Danish drugmaker will now wait for a thumbs up from the European Commission (EC)--and assuming it gets it, Novo "expects to launch Saxenda in several European markets starting in 2015," the company said in a statement seen by Reuters.
But by then, it may have a new rival waiting. CHMP in December gave its blessing to Orexigen's ($OREX) new weight-loss therapy, Mysimba--or Contrave in the U.S., where it nabbed the FDA's favor last fall. That endorsement came with a caveat, however: If patients haven't lost at least 5% of their body weight after 16 weeks on Orexigen's product, they must stop therapy thanks to the potential cardio risks that come along with prolonged use.
The regulatory action in Europe follows a market fill-out in the U.S., where Saxenda and Contrave recently joined first-to-market Qsymia from Vivus ($VVUS) and Belviq from Arena ($ARNA) on the FDA's green-light list. And while Qsymia and Belviq have had time on their side, they haven't been able to do too much with it. Analysts are looking to the newcomers to jump-start a market that's lagging despite tremendous potential: The CDC considers more than a third of U.S. adults obese, and just 2 million of 100 million potential American patients were receiving a prescription weight-loss aid at the time of Contrave's approval, Orexigen's Chief Commercial Officer Mark Booth said in a September presentation.
All things considered, analysts expect the newer therapies to eventually eclipse slow starters Qsymia and Belviq. Wells Fargo's Matthew Andrews has said he sees Contrave raking in $634 million in 2020 sales, which could swell to $1.2 billion if it nets a diabetes indication. That measures up to forecasts of $481 million for Belviq and $396 million for Qsymia; Bloomberg analyst estimates peg Saxenda's 2017 top-line haul at $429 million.
- read Novo's release
- get more from Reuters
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