Ralph Kern from Biogen: Zinbryta Data Stays Positive as Approval Process Winds Down

Looking to become the latest addition to the field of treatment options for multiple sclerosis Zinbryta continues to show positive results during clinical trials as it awaits the final steps of the regulatory approval process in the United States and elsewhere.

Ralph Kern, MD, of Biogen, described the approval process and what it could mean for the treatment of the condition during the American Academy of Neurology's annual meeting in Vancouver.

Kern said Zinbryta has a targeted mechanism of action which modulates the immune system and regulates inflammation, and is delivered as a once monthly injection. Currently the medication is in phase 3 lage stage trials which are expected to run through the middle of June.

As opposed to oral medications or ones delivered as an intravenous infusion, Kern said the injection option takes a minute. “It is a very short inconvenience for patients,” Kern said. The injection delivery method is less frequent than other delivery methods of other MS therapies.

Zinbryta is geared toward those with relapsing and remitting multiple sclerosis as a targeted therapy. “This targets a provided pathway that was thought to be active in MS, and create a new option for patients who weren’t having their disease controlled,” Kern said.

One of the other advantages according to Kern is that the drug is a targeted therapy meant to not deplete the immune system, he said. The decreased inflammation could lead to improved cognitive function.

Among the adverse events were a skin reaction to the injection, which is resolved with an anti-histamine for example, and adverse effects to the liver, which is picked up by liver-monitoring blood tests. Regular liver-monitoring blood tests might be necessary.

At the conference in Canada Biogen featured the results of the latest studies for Zinbryta as well as continuing data for Lemtrada which is already in the field for patient care.