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)
Radical cleansing will start a new era in Turkey, says the head of the Turkish Cooperation and Development Agency (TIKA)
EU Commissioner for Jobs, Growth and Investment and Competitiveness Jryki Katainen told reporters "we should forget this phrase" when asked if that meant granting market economy status to China.
Militancy has reduced revenue from oil industry by half, senior official says
The grant was signed Monday in Nairobi to mitigate impact of forced displacements on refugee hosting communities in East Africa
The EU Trade Commissioner Malmstrom made the comment while speaking to Chinese students in Beijing ahead of a China-EU summit.
Trade Ministers Meeting in Shanghai concludes with pledge to push efforts toward trade liberalization and facilitation
Brexit raises uncertainty for consumer, investor confidence, ratings agency says
Bank of England Governor Mark Carney eases lending rules after vote for Brexit
Banca Monte dei Paschi di Siena, or BMPS, is among the banks at the forefront of those concerns with gross bad loans amounting to 46.9 billion euros ($52 billion).
Fund to be used in support of education, health, municipal, socio-economic support for refugees in Turkey
Turkish Statistical Institute says energy prices drive fall in imports
Given all the uncertainty, investors were pricing in a chance of a rate cut with some analysts expecting the Bank of England to consider quantitative easing to cushion the economy
The Egyptian stock index was down 5.8 percent in early afternoon.
The pound sterling sees its lowest level against the the US dollar in over 30 years