Look for Drugs and Conditions

Reference pic

Novartis' post-steroid GvHD treatment becomes the first to receive EC approval

DTMT Network

Swiss pharmaceutical giant, Novartis has announced that the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic graft-versus-host disease (GvHD) who have an inadequate response to corticosteroids or other systemic therapies.

The approval makes Jakavi the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of steroid-refractory graft-versus-host disease (GvHD), a common and potentially life-threatening complication that arises in approximately half of patients following allogeneic stem cell transplants, the company said.

 “Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” Dr Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany said.

“The approval of Jakavi offers healthcare providers and patients with GvHD who remain dependent on or refractory to steroids a new way to manage this debilitating and life-threatening condition,” he added.

Novartis informed that the approval follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency, based on the Phase III REACH2 and REACH3 trials in which the drug demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT).

Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GvHD patients, the statement by Novartis added.

“Five out of ten patients who receive allogeneic stem cell transplants experience the serious and sometimes fatal symptoms of graft-versus-host disease,” says Marie-France Tschudin, Novartis President of Innovative Medicines International and Chief Commercial Officer.

“Jakavi, with this new indication in GvHD, will help to redefine treatment for patients who do not respond to first-line care,” she added.

GvHD occurs when donor cells see the recipient's healthy cells as foreign and attack them. Symptoms of GvHD can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs and joints. Approximately 50% of allogeneic stem cell transplant recipients will develop either acute or chronic GvHD. Both acute and chronic GvHD can be fatal and until now both have lacked an established standard of care for patients who do not adequately respond to first-line steroid treatment. Currently, there are no other approved therapies for the treatment of GvHD after steroid failures.

It may be recalled that Novartis licensed ruxolitinib from Incyte for development and commercialisation outside the United States.


0 Comments
Be first to post your comments

Post your comment

Related Articles

Ad 5