Shares in UCB are on the rise this morning after the Belgian drugmaker said a meeting with the US regulators to define the path forward to get Cimzia approved for rheumatoid arthritis have been very positive.

The Brussels-based firm has met with the US Food and Drug Administration and “clarified the requirements” for the approval of its Biologics License Application for the anti-tumour necrosis factor agent Cimzia (certolizumab pegol) for the treatment of RA. The agency approved the drug for Crohn’s disease in April.

However at the beginning of this year, the FDA issued a complete response letter relating to the RA indication and requested a new safety update with all clinical data including new information generated since the filing of the BLA last February. Now, the regulator has told UCB that no additional studies, either clinical or non-clinical, are needed to fulfill this request.

The BLA was based on a clinical programme which included more than 2,300 patients, representing more than 4,000 patient years of experience, UCB said. “Due to the already rich database available…we anticipate submitting the full response for Cimzia in the second quarter," said the firm’s chief medical officer, Iris Loew-Friedrich.

Getting approval for the RA indication would help UCB plug the gap in sales resulting from the loss of patent protection on its biggest earners – the allergy drug Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam). The drug is also undergoing a review by the European authorities for the treatment of RA.

Investors were pleased with this latest development and at 10.20 UK time this morning, UCB shares were up 3.1% to 26.05 euros.