Novartis and Incyte to Test Cancer Drug Jakavi in COVID-19

 

Novartis announced that, with Incyte, it is launching a Phase III clinical trial to determine if their cancer drug Jakavi (ruxolitinib) can be used to treat COVID-19.

Jakavi is an oral inhibitor of the JAK1 and JAK 2 tyrosine kinases. It is approved for the treatment of polycythemia vera (PV) in patients resistant to or intolerant of hydroxyurea and for disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post-polycythemia vera MF or post-essential thrombocythemia. Novartis licensed it from Incyte for development and commercialization in certain indications outside the U.S.

Specifically, they are looking to see if Jakavi can be used to treat the cytokine storms associated with COVID-19. A cytokine storm is a massive immune overreaction that leads to the worst of the respiratory complications in COVID-19.

“Novartis is taking a number of steps to address the urgent needs arising from the COVID-19 pandemic, including the evaluation of our existing therapies to assess if any can be utilized beyond their approved indications,” said John Tsai, head of Global Drug Development and chief medical officer of Novartis. “The potential that Jakavi could lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation is encouraging and absolutely merits further investigation.”

The company is launching a compassionate use program for COVID-19 access, while make a concerted effort to ensure there’s enough Jakavi available for approved indications.

Novartis and Incyte are not the only pharma companies evaluating existing drugs for COVID-19. Roche is testing its arthritis medication Actemra in the disease and Sanofi and Regeneron are testing their arthritis drug Kevzara. As in the case of Jakavi, there is some preclinical research as well as experimental use in Chinese patients that suggest these drugs can control the cytokine storms, improving patients’ chances of survival.

Novartis also is one of the companies that manufactures hydroxychloroquine, the malaria drug that has been touted as a possible treatment for COVID-19. The company has committed 130 million doses to the pandemic response. Other companies doing so include Mylan, Teva Pharmaceutical and Bayer.

The clinical trial design hasn’t been finalized yet, but will assess Jakavi in combination with standard-of-care (SoC) treatments compared to SoC alone, in patients with severe COVID-19 pneumonia.

“We are now moving rapidly to finalize the study plan and then to enroll eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial,” said Tsai.

Yesterday, Novartis reported that the planned sales of 300 of its Sandoz division’s dermatology and generic drug assets for $1 billion by Aurobindo Pharma was called after the Federal Trade Commission (FTC) failed to approve it. The deal was initiated in November 2018, with Aurobindo paying $900 million upfront with another $100 million in milestone payments.

In a filing with the U.S. Securities and Exchange Commission (SEC), Aurobindo wrote, “Aurobindo today announced the mutual agreement with Sandoz Inc. to terminate the agreement to buy the Sandoz U.S. generic oral solids and dermatology businesses from Sandoz Inc. This decision was taken as approval from the U.S. Federal Trade Commission for the transaction was not obtained within anticipated timelines.”