2020-11-15| Trials & Approvals

Roche’s Influenza Drug Bags Recommendation for EU Approval

by Tulip Chakraborty
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Influenza is a viral infection that targets our respiratory system, leading to fever, headache, and in extreme cases, death. Influenza, commonly referred to as the flu, is a seasonal disease, which accounts for three to five million cases every year, and close to 650,000 deaths every season. Even with flu vaccines available, the various strains of the influenza virus make it close to impossible to be completely immune to this virus. On November 13th, Roche announced that its flagship drug Xofluza was recommended for influenza treatment by European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to the EU.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, said, “Today’s CHMP recommendation brings patients with influenza one step closer to potentially benefiting from Xofluza’s oral one-dose regimen, setting adults and adolescents on the path to feeling better sooner compared to placebo. We believe that access to effective antivirals for influenza, and particularly their use in the prophylactic setting, could help reduce the strain of the COVID-19 pandemic on healthcare systems in Europe.”



Xofluza is a first-in-class oral medication that has been effective against various flu strains, including drug-resistant forms. This drug targets the cap-dependent endonuclease protein, which is important for viral replication in the host. The drug is already approved by the FDA in the USA and was the first influenza drug to be approved in 20 years. The recommendation by CHMP is based on the results from 3 different clinical trials.


Clinical Trials

CAPSTONE-1: This Phase 3, double-blinded trial aimed to study the safety and efficacy of Xofluza in a total of 1,436 non-high-risk individuals. The study met the primary endpoint of symptom alleviation with the flu symptoms reducing in 53.7 h compared to 80.2 h in the placebo arm. The most common adverse events reported were diarrhea, bronchitis, and nausea (1.3%).

CAPSTONE-2: This Phase 3 trial aimed at evaluating the efficacy of a single dose of Xofluza compared to placebo and Roche’s blockbuster flu drug, Tamiflu. A total of 2184 high-risk patients were recruited to receive a single dose of either 40mg or 80mg of Xofluza (according to body weight), placebo, or Tamiflu twice a day. Xofluza met the primary endpoint by significantly improving symptoms (73.2 h) than the placebo (102.3 h).

BLOCKSTONE: This Phase 3, placebo-controlled study aimed to study the safety and efficacy of a single-dose of Xofluza, as a preventive medication, in family members of patients living in the same household. The drug demonstrated a significant prophylactic effect in people exposed to an infected household contact. Approximately 1.3% of household members were infected with flu post drug treatment compared to 13.2% in the placebo group. No new adverse events were noted.



Roche enjoyed a great run with Tamiflu, earning billions of dollars in revenue till its patent expired, and several generic drugs flooded the market. With this next-generation drug, Xofluza, Roche is trying to regain its hold. The company is trying to capitalize on the single dosage administration and the preventive potential of Xofluza. However, till now, these marketing strategies have not been successful in the US. The drug only made $30 million, which is not comparable to billions that Tamiflu racked in. With the EU approval recommendation, it will be interesting to see if Roche can make up lost ground.

By T. Chakraborty, Ph.D.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Vir Biotechnology Showcases Data on a Potential Therapy for Influenza



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