Gilead Sciences ($GILD), which this week got FDA approval for its new blood cancer drug Zydelig (idelalisib), has now gotten a recommendation for its use in Europe. But the celebration for the double header comes with some caution because competitor Imbruvica from Johnson & Johnson ($JNJ), which got a head start in the U.S., also received a nod from EU authorities today.
The Committee for Medicinal Products for Human Use (CHMP) today said that it recommended both drugs for treatment of adults with chronic lymphocytic leukemia (CLL) who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy. Additionally, Zydelig is recommended for adults with follicular lymphoma that has not responded to two previous treatments. Imbruvica was recommended to treat adults with relapsing mantle cell lymphoma that is not responding to other treatments.
Zydelig, a first-in-class PI3k inhibitor, received approval from the FDA on Wednesday for CLL and two types of non-Hodgkin's lymphoma in patients who've already used at least two other therapies. Analysts' forecasts have said the drug could hit $1.5 billion by 2017.
Zydelig was beaten to the U.S. market by Imbruvica, which got its FDA approval in November for mantle cell lymphoma and in February for CLL, giving doctors an early look at a drug from a company with more experience in selling cancer meds than Gilead. But Gilead will get a cleaner shot at the EU market with the same-day recommendations.
The European Medicines Agency (EMA) generally takes CHMP recommendations and approves drugs within a few months. Then it will be up to the individual countries to decide and at what price. In the U.S., Gilead priced Zydelig at a slight discount to Imbruvica and another competitor, at $7,200 compared with $8,200. It is approved for use as a combo regimen, with Rituxan or another med, which is expected to elevate its cost as a treatment to $12,000 per month.
In the EU, where the cost watchdogs of national health systems bargain for discounts, authorities can be expected to try to play one company off the other to get the best deals. Gilead certainly knows that routine with its launch this year of Sovaldi, the hepatitis C treatment that last quarter racked up $3.48 billion in sales worldwide, $3 billion of that in the U.S. and most of the rest in Europe. It has been well received by doctors there but is hitting some price-shock pushback from governments.
- here's the EMA announcement