Teva Pharmaceutical Industries gains FDA approval for monthly olanzapine

A once-monthly olanzapine injection gained U.S. approval Friday as Teva Pharmaceutical Industries Ltd. NYSETEVA prepared to launch WELTRUZA for adults with schizophrenia. The Oct. 9 company release says the medicine will be available in three strengths in the coming weeks.

The FDA decision covers a subcutaneous injection, which Teva says needs no loading doses, oral supplementation or required observation after administration. The WELTRUZA product site describes an eight-week study in adults with an acute worsening of schizophrenia and says the treatment improved symptom scores against placebo at week eight.

Teva is an Israel-based pharmaceutical company with a U.S. branded neuroscience business and a large generics operation.

Teva shares closed at US$39.25 in New York on Oct. 8, according to the NYSETEVA quote timestamped 4 p.m. EDT; that close preceded Friday's announcement. The company scheduled an investor webcast for 8 a.m. EDT on Oct. 9 to discuss the approval and launch.

Trial Tested Three Doses Against Placebo

In its Feb. 20 application acceptance release, Teva says the Phase 3 SOLARIS trial randomized 675 adults to three injection doses or placebo for its first eight weeks. Participants who completed that period were randomized equally among the three active-dose groups for the next 48 weeks, Teva said. The company describes the later period's objective as assessing safety and tolerability.

The approved strengths are 318 mg, 425 mg and 531 mg, according to the Oct. 9 release. Teva says they correspond to oral olanzapine doses of 10 mg, 15 mg and 20 mg a day, respectively. The approval announcement also reports improvement in illness severity and personal and social functioning, though its opening summary does not quantify the symptom score difference against placebo.

In its Oct. 9 release, Teva lists increased weight, sleepiness, headache, constipation and injection site reactions among common adverse events. It reports discontinuation for common adverse events in 5 per cent of WELTRUZA recipients and 4 per cent of placebo recipients. Weight gain and metabolic changes remain part of the drug's safety profile, the company said.

"WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape," Teva executive vice-president Chris Fox said in the Oct. 9 release.

Launch Will Test the Monitoring Advantage

Teva said in February that the existing long-acting olanzapine formulation required administration in a certified facility and three hours of observation under an FDA risk management program. The company says WELTRUZA does not require that post-injection observation, a practical distinction for clinics arranging repeat appointments. That statement concerns observation after an injection, not the need to watch for weight gain or metabolic effects during treatment.

Alkermes plc NASDAQALKS lists monthly and every-two-month intramuscular aripiprazole injections for schizophrenia on its ARISTADA patient page. The page says the two-month option follows a starting regimen. SOLARIS did not compare ARISTADA with WELTRUZA, so it cannot establish which treatment works better.

The State Street SPDR S&P Pharmaceuticals ETF NYSEARCAXPH stood at US$63.63 at 8 p.m. EDT on Oct. 8, a sector price recorded before Teva's announcement. For Teva, the next commercial evidence will be the first prescriptions after availability in the coming weeks; Friday's approval itself provides no sales figure.

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Teva's next dated event is its Oct. 9 investor webcast at 8 a.m. EDT, when management is due to discuss WELTRUZA's approval and U.S. rollout. The announced availability window remains the coming weeks.