European regulators are still probing the safety of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, delaying an expected update on the medicine until April.
The European Medicines Agency (EMA) initially aimed to give an update on the medicine by March 16 but a spokeswoman said on Friday that the review had not yet been finalised. As a result, an announcement is now due on April 19 or 20.
The delay leaves a question mark over the product, which has seen its prospects clouded by concern about serious heart problems.
But there was also good news for Gilenya as Britain's healthcare cost-effectiveness watchdog NICE, in an about-turn, decided it was ready to recommend its use on the state health service.
Gilenya, the first multiple sclerosis (MS) pill of its kind, is seen by analysts as a potential blockbuster with annual sales of $2 billion by 2015, according to consensus forecasts collected by Thomson Reuters Pharma.
However, that is down on the $2.2 billion seen at the end of 2011 as doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.
Those cases prompted the EMA to start its review in January, when it also advised doctors to continuously monitor patients for six hours after giving them a first dose. The U.S. Food and Drug Administration (FDA) is also looking into the drug.
Novartis said in a statement it was working with the EU regulator to finalise the label for Gilenya and was also liaising with the FDA on its review.
Gilenya represents a significant change in MS treatment, since existing medicines like beta interferons and Elan and Biogen Idec's Tysabri must be injected.
Rival oral MS treatments in development include BG-12 from Biogen, teriflunomide from Sanofi and laquinimod from Teva.
Britain's National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, initially said it was unclear if Gilenya was any better than existing treatments.
It changed its mind after Novartis presented data showing benefit in a subgroup of adults with highly active disease, whose relapses had increased or stayed the same compared with the previous year despite them taking beta interferons.
Carole Longson, director of NICE's health technology evaluation centre, said it was now clear Gilenya was a cost-effective option for these patients, provided Novartis supplied the drug at the discounted price it previously suggested.
A NICE spokeswoman said the size of the discount remained confidential. The list price for 28 capsules is 1,470 pounds ($2,300) or just over 19,000 pounds per person for a year.
Novartis and Britain's MS Society welcomed the final NICE decision, which is expected to be officially published next month. ($1 = 0.6376 British pounds)
According to the ratings agency Moody’s, Iran is fiscally and structurally well placed to come back into the global economic scene
PM Davutoglu meets the heads of the world's largest companies as he promotes Turkish economic interests at World Economic Forum
Fund cuts global growth forecasts for both 2016 and 2017 by 0.2 percentage points
'Runaway inequality has created a world where 62 people own as much wealth as the poorest half of the world’s population'
At a meeting in Vienna on Friday, the Organization of the Petroleum Exporting Countries decided against cutting output to raise prices
OPEC has agreed to raise its output ceiling to 31.5 million barrels per day
OPEC's poorer nations, led by Venezuela, want a cut to help boost prices
Move gives international recognition to renminbi, fund's Christine Lagarde says
Summit is expected to provide member states with opportunity to consult, exchange views on the most important issues concerning them in the framework of the Gas Exporting Countries Forum
Slowdown in Chinese economy, rising oil stocks in US, and oversupply from OPEC are all factors making price of oil lower
'World is more connected than ever before. More and more developing countries are seeking to join global trade networks,' WTO director-general says
European Central Bank is ready to use ‘all instruments available’ to stimulate the eurozone economy, Draghi says
Kazakhstan has overtaken Australia as the lead supplier of uranium for US reactors.
Depreciation of emerging market currencies, combined with low commodities prices, have made investors around the globe nervous