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)
Index sees increase of 1.1 percent from April, according to official data
Oil prices tumble after OPEC extends production cuts
3 major indexes close with gains for fourth trading day in row
Agency expects China's financial strength ‘to erode somewhat over the coming years’
The British capital's FTSE 100 index of leading blue-chip companies wobbled between gains and losses during the day, before finally closing down 0.2 percent.
BIST 100 index opens 0.17 percent lower; US dollar/Turkish lira rate stands at around 3.57
With his tough rhetoric on winning back American jobs, President Trump's elevation to the White House has raised serious fears over a new protectionist era.
Southeast Asia's third-biggest economy expanded 5.6 percent on-year in January-March period, compared with 4.1 percent in the same period last year and 4.5 percent in October-December.
Uber Freight aims to connect truckers with shippers by taking piece of $256B industry
BIST 100 index falls 0.27 percent while US dollar/Turkish lira rate stands at 3.59
The White House, already reeling over a number of controversies, denied that Trump pressured former FBI chief James Comey to stop a probe into ex-national security advisor Michael Flynn over contacts with Russia.