HBV drug Tyzeka discontinued

Novartis announced it is discontinuing production of its hepatitis B drug Tyzeka; supplies of the film-coated tablets should be available through the end of December 2016.

“We have made this decision following a routine evaluation of our product portfolio where we weigh in a number of different factors, including the availability of alternative medications,” Eric Althoff, global media relations, Novartis, told Healio.com/Hepatology. The FDA has been notified of Novartis’ plans.

Tyzeka (telbivudine, Novartis) received FDA approval in 2006. A clinical trial involving 1,367 patients with chronic HBV who received telbivudine produced evidence of antiviral effectiveness, including suppression of HBV and improvement in liver inflammation comparable to epivir-HBV (lamivudine), according to a FDA press release.

Novartis company literature reported an open-label trial involving 655 patients with HBV who previously underwent blinded therapy. The literature showed grade 3/4 CK elevations occurred in 16% of the patients, with most of these being transient and asymptomatic, and returned to baseline levels or resolved spontaneously. Potential adverse effects include peripheral neuropathy, myopathy, lactic acidosis and severe hepatomegaly with steatosis, and — after the stopping treatment — worsening of hepatitis.

In other research, telbivudine did not increase renal effects in patients with HBV and reduced HBV mother-to-child transmission. – by Janel Miller

Disclosures: Althoff is employed by Novartis.