May 31 (Reuters) - The European Medicines Agency (EMA)

has recommended the use of Pfizer's ( PFE ) gene therapy for a

rare bleeding disorder called hemophilia B, which typically

requires regular infusions of a blood-clotting protein, the

regulator said on Friday.

The regulator has recommended granting a 'conditional

marketing authorization,' which is for the approval of a

medicine addressing unmet medical needs of patients based on

less comprehensive data than normally required.

The decision comes months after the one-time therapy

received regulatory approvals in the United States and Canada,

where it is branded Beqvez.

Any recommendation by the EMA's Committee for Medicinal

Products for Human Use (CHMP) has to be formally approved by the

European Commission, which usually follows the regulator's

decision.

The therapy carries a price tag of $3.5 million in the

U.S. - the same as Australian drugmaker CSL Ltd's ( CMXHF ) rival

gene therapy Hemgenix.

In the EU, it will be sold under the brand name

Durveqtix.

People with hemophilia have a fault in a gene that

regulates production of proteins called clotting factors, which

can cause spontaneous as well as severe bleeding following

injuries or surgery. It predominately affects males.

The therapy is designed to stimulate production of the

protein, called factor IX (FIX), by the patient's own body

instead of intravenous infusions of FIX multiple times a week or

a month.

The recommendation comes based on a late-stage trial in

which a single dose of the therapy was shown to work as well as

standard-of-care protein infusions after a year, with bleeding

completely eliminated in 60% of patients versus 29% who received

infusions.

Pfizer ( PFE ) said it will continue to monitor for long-term

durability and safety of the treatment over the course of 15

years.

More than 38,000 people worldwide are living with hemophilia

B, said Pfizer ( PFE ), citing the World Federation of Hemophilia.