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After the fall in sales of Tamiflu, Roche switched to the next-generation flu treatment, Xofluza, as a follow-up to the aging blockbuster. Getting a nod from the FDA as a flu prevention is an important part of this puzzle, and Xofluza may well be on the way with new data.
Xofluza reduced the spread of influenza after exposure to an infected household member by 86% compared to placebo, according to data from Roche's Phase 3 Blockstone study, presented at the Options X 2019 conference in Singapore on Sunday.
Only 1.9% of patients treated with Xofluza in the trials contracted influenza, compared with 13.6% of patients who received placebo, Roche said. Xofluza also achieved significant results in the subgroups: Roche's drug beat placebo in influenza A subtypes, in household contacts at high risk of influenza-related complications, and in children of less than 12 years.
The latest data could also be a compelling argument for payers, according to Barry Clinch, Global Head of Product Development for Influenza and Infectious Diseases at Roche.
"If approved by the FDA, we believe that Xofluza in the preventative setting will be favorably considered by payers as there are significant health system implications and economic costs associated with the flu," Clinch said via email. "It is important for physicians and from a public health perspective to have new mechanisms of action to combat the emergence of resistance to existing mechanisms."
Data did not match all roses for Xofluza: the drug had an adverse event rate of 22.2%, compared with 20.5% for placebo, but Roche rated the safety profiles as "comparable" .
RELATED: Roche's Xofluza Wins Influenza Prevention Trial, Offering Sales Hope with Tamiflu Craters
In Singapore, Roche also released data from its Ministone-2 study showing that Xofluza at one dose exceeded Tamiflu to reduce the rate of pediatric patients with at least one influenza symptom. 46% of patients reported at least one symptom of influenza after 29 days, compared to 53.4% in the Tamiflu arm, said Roche.
Xofluza also reduced the time that patients were contagious (a measure known as "viral shedding") of more than two days on Tamiflu. In patients treated with Xofluza, the contagious period was recorded at a median of 24.2 hours versus 75.8 hours for Tamiflu.
Strong Xofluza data could help Roche offset the drop in sales of Tamiflu, which became generic three years ago. In the first half of 2019, sales of Tamiflu were only $ 277 million, down 29% from the same period in 2018.
In addition to the preventive treatment, Roche is also looking for indications of Xofluza as a single-dose oral therapy in people at high risk of influenza-related complications, in addition to standard neuraminidase inhibitors, and in patients under 1 year of age. . Said Clinch.
Regarding sales, Xofluza had not yet paid the bill to Roche after its initial approval in late 2018. In the first half, the drug had generated only $ 6 million in sales, ranking as the second lowest Roche's portfolio relative to Polivy. FDA approved in June.
Xofluza, however, has some hopes: Shionogi partner, who owns the rights of the drug in Japan, recorded domestic sales of $ 243 million in fiscal year 2018.
RELATED: Sanofi Acquires Non-prescription Duties on Roche's Tamiflu to Switch Rx Switch to Over-the-Counter
With impending copies, Roche signed an exclusive agreement with Sanofi in July to transfer OTC rights to Tamiflu if approved by the FDA by Rx / OTC. Under this agreement, Sanofi will handle FDA negotiations for OTC failover and all future marketing operations. In addition, Sanofi has the first rights in over-the-counter rights in other markets.
Obtaining an OTC approval will not be easy: with an antiviral drug like Tamiflu, the additional question is whether a wider use by consumers could increase the risk of viral resistance. However, a 2012 study in New Zealand – the first country to offer Tamiflu without a prescription – found that five years without a prescription for Tamiflu did not seem to stimulate the development of resistance or cause a drop in influenza vaccination rates.
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