Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion recommending the approval of Jakavi (ruxolitinib), an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, for an additional indication.

The CHMP has recommended approval of the drug to treat patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease (GvHD) who have an inadequate response to corticosteroids or other systemic therapies.

Per the company, a potential approval will make Jakavi the first JAK1/2 inhibitor available for patients with GvHD in Europe.

The CHMP positive opinion was based on data from the phase III REACH2 and REACH3 clinical studies wherein Jakavi demonstrated superiority versus best available therapy (BAT) in patients with steroid-refractory and steroid-dependent acute and chronic GvHD, respectively.

The drug is already approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. It is also approved to treat disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF.

We note Novartis licensed ruxolitinib from Incyte INCY for development and commercialization outside the United States.

Incyte markets ruxolitinib as Jakafi in the United States for PV patients who have had an inadequate response to or are intolerant of hydroxyurea, for adults with intermediate or high-risk MF and for steroid-refractory acute GvHD and chronic GvHD after the failure of one or two lines of corticosteroids or other systemic therapy.

Concurrently, the CHMP also recommended approval of Kymriah (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

Upon approval, r/r FL would be the third indication for which Kymriah is available to patients in the European Union. The therapy is currently approved for the treatment of pediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, and adult patients with r/r diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.