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The Food and Drug Administration has approved the subcutaneous administration of vedolizumab (Entyvio SC, Takeda) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous administration of vedolizumab.
The FDA approved the intravenous formulation of the biologic in 2014 for patients with moderate to severe UC and Crohn’s disease who failed or cannot tolerate other therapies.
The approval of subcutaneous (SC) vedolizumab was based on results from the phase 3, randomized, double-blind, placebo-controlled VISIBLE 1 trial.
The trial assessed the safety and efficacy of maintenance therapy with SC vedolizumab in adult patients with moderately to severely active UC who achieved clinical response at week 6 following two doses of intravenous vedolizumab.
At week 6, 162 patients were randomly allocated (2:1) to vedolizumab or placebo by subcutaneous injection every 2 weeks. The primary endpoint was clinical remission at week 52, defined as a total Mayo score of 2 or less and no individual subscore greater than 1.
At week 52, nearly half (46%) of patients who received vedolizumab SC maintenance therapy achieved clinical remission, compared with 14% of those who received placebo SC (P < .001).
The safety profile of SC vedolizumab was “generally consistent” with that of intravenous vedolizumab, with the addition of injection-site reactions, the drugmaker, Takeda, said in a news release.
The most common adverse reactions with intravenous vedolizumab are nasopharyngitis, headache, arthralgia, nausea, pyrexia (fever), upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in the extremities.
SC vedolizumab “can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients,” according to Bruce E. Sands, MD, AGAF, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He provided a statement in the Takeda news release.
“I appreciate now having a subcutaneous administration option that provides a clinical profile consistent with Entyvio intravenous while also giving me and my appropriate UC patients a choice of how they receive their maintenance therapy,” Dr. Sands said.
The FDA is currently reviewing Takeda’s biologics license application for subcutaneous administration of vedolizumab in the treatment of adults with moderately to severely active Crohn’s disease.
Dr. Sands is a paid consultant of Takeda.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the subcutaneous administration of vedolizumab (Entyvio SC, Takeda) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous administration of vedolizumab.
The FDA approved the intravenous formulation of the biologic in 2014 for patients with moderate to severe UC and Crohn’s disease who failed or cannot tolerate other therapies.
The approval of subcutaneous (SC) vedolizumab was based on results from the phase 3, randomized, double-blind, placebo-controlled VISIBLE 1 trial.
The trial assessed the safety and efficacy of maintenance therapy with SC vedolizumab in adult patients with moderately to severely active UC who achieved clinical response at week 6 following two doses of intravenous vedolizumab.
At week 6, 162 patients were randomly allocated (2:1) to vedolizumab or placebo by subcutaneous injection every 2 weeks. The primary endpoint was clinical remission at week 52, defined as a total Mayo score of 2 or less and no individual subscore greater than 1.
At week 52, nearly half (46%) of patients who received vedolizumab SC maintenance therapy achieved clinical remission, compared with 14% of those who received placebo SC (P < .001).
The safety profile of SC vedolizumab was “generally consistent” with that of intravenous vedolizumab, with the addition of injection-site reactions, the drugmaker, Takeda, said in a news release.
The most common adverse reactions with intravenous vedolizumab are nasopharyngitis, headache, arthralgia, nausea, pyrexia (fever), upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in the extremities.
SC vedolizumab “can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients,” according to Bruce E. Sands, MD, AGAF, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He provided a statement in the Takeda news release.
“I appreciate now having a subcutaneous administration option that provides a clinical profile consistent with Entyvio intravenous while also giving me and my appropriate UC patients a choice of how they receive their maintenance therapy,” Dr. Sands said.
The FDA is currently reviewing Takeda’s biologics license application for subcutaneous administration of vedolizumab in the treatment of adults with moderately to severely active Crohn’s disease.
Dr. Sands is a paid consultant of Takeda.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the subcutaneous administration of vedolizumab (Entyvio SC, Takeda) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous administration of vedolizumab.
The FDA approved the intravenous formulation of the biologic in 2014 for patients with moderate to severe UC and Crohn’s disease who failed or cannot tolerate other therapies.
The approval of subcutaneous (SC) vedolizumab was based on results from the phase 3, randomized, double-blind, placebo-controlled VISIBLE 1 trial.
The trial assessed the safety and efficacy of maintenance therapy with SC vedolizumab in adult patients with moderately to severely active UC who achieved clinical response at week 6 following two doses of intravenous vedolizumab.
At week 6, 162 patients were randomly allocated (2:1) to vedolizumab or placebo by subcutaneous injection every 2 weeks. The primary endpoint was clinical remission at week 52, defined as a total Mayo score of 2 or less and no individual subscore greater than 1.
At week 52, nearly half (46%) of patients who received vedolizumab SC maintenance therapy achieved clinical remission, compared with 14% of those who received placebo SC (P < .001).
The safety profile of SC vedolizumab was “generally consistent” with that of intravenous vedolizumab, with the addition of injection-site reactions, the drugmaker, Takeda, said in a news release.
The most common adverse reactions with intravenous vedolizumab are nasopharyngitis, headache, arthralgia, nausea, pyrexia (fever), upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in the extremities.
SC vedolizumab “can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients,” according to Bruce E. Sands, MD, AGAF, chief of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He provided a statement in the Takeda news release.
“I appreciate now having a subcutaneous administration option that provides a clinical profile consistent with Entyvio intravenous while also giving me and my appropriate UC patients a choice of how they receive their maintenance therapy,” Dr. Sands said.
The FDA is currently reviewing Takeda’s biologics license application for subcutaneous administration of vedolizumab in the treatment of adults with moderately to severely active Crohn’s disease.
Dr. Sands is a paid consultant of Takeda.
A version of this article first appeared on Medscape.com.