The first rival treatment to Amgen’s portfolio of anaemia drugs has been approved in the US.

Omontys (peginesatide) has been developed by Affymax and Takeda to treat anaemia in adult dialysis patients who have chronic kidney disease (CKD). This makes it a rival for Amgen’s Epogen, which was first approved in 1989 and has been a blockbuster earner for many years.

Omontys is administered just once a month, giving it a major advantage over Epogen, which needs to be taken up to 12 times a month.

The drug is a new erythropoiesis-stimulating agent (ESA), that aids in the formation of red blood cells by stimulating the bone marrow to produce more red blood cells, and thereby reduce the need for transfusions.

The approval is a long-awaited victory for the marketing partners, who have fought to overcome FDA concerns about cardiovascular risk seen in clinical trials since 2010.

Analysts believe that the drug could hit peak sales $700 million or more, but is unlikely to reach the multi-billion dollar figures reached by Epogen.

Safety concerns about Epogen and Amgen’s other anaemia drugs have seen sales drop significantly in recent years, and the market is now a fraction of its size five years ago.

The FDA retains its own concerns about the safety of Omontys. Two trials of the drugs showed patients with CKD not on dialysis experienced increased specific cardiovascular events, and for this reason the FDA has blocked its use in these patients, and in patients with cancer-related anaemia. 

The drug’s label also states that it should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anaemia. This restricts the size of the market in which it can compete with Epogen, which is approved in these patients.

Amgen has also anticipated the competition by striking a deal with the biggest US provider of dialysis services, DaVita.  The companies recently signed an exclusive long-term contract a few months ago to include use of Epogen, and a similar but non-exclusive deal with Fresenius Medical Care has also been signed. 

Takeda is to market the product outside the US, and will share the US market with Affymax, which has never brought a product to market before.

The approval comes with a Risk Evaluation and Mitigation Strategy (REMS), which includes a post-marketing requirements to conduct an observational study and a randomised controlled trial to evaluate cardiovascular safety and safety of long-term use in adult patients on dialysis, in particular in the incident patient population.

These two studies must be completed with final reports submitted in 2018 and 2019, respectively.

The companies will also have to carry out of paediatric studies with target dates for completion between 2016 and 2027. Letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS), to inform them that Omontys is not indicated in patients with CKD not on dialysis.

Takeda has filed a European marketing application for the drug with the EMA.

The FDA approval is also welcome news for Nektar, which will earn single-digit royalties for its contribution to the drug delivery technology.

Andrew McConaghie

...