People with multiple sclerosis will soon be able to take the first daily pill to treat their condition.
It should be available in the UK within a few months, according to the MS Society.
Gilenya, produced by Swiss firm Novartis, is already sold in Russia and in the US and will be marketed in the UK in the coming months.
The Committee for Medicinal Products for Human Use, comprising European Medicines Agency specialists, said the EU regulator should give the green light to the drug which would open the door to an EU-wide licence.
Gilenya is the first pill that can be taken daily, replacing the need for injected MS treatments.
The MS Society, a UK charity, has welcomed the development. Its policy and research director Jayne Spink said: "The news about Gilenya is great for people with MS. The availability of a tablet to treat the condition will give people more choice and for many will come as a welcome relief from frequent injections.
"All being well, Gilenya could be available for people with MS later this year."
The drug is said to be intended for those who have two serious forms of relapsing-remitting MS. Currently many patients with the disease have to self-inject with drugs such as beta interferon or travel to hospital for treatment.