Novartis Says Its Oral Multiple Sclerosis Therapy Reduces Relapses
既藥廠Merk默克之後, 又一家藥商Novartis將提供了MS的口服藥 : FTY720
(RTTNews) - Novartis AG (NVS: News ) said Wednesday that initial results from a late-stage study showed that treatment with oral FTY720 significantly reduced relapses and disability progression in patients with multiple sclerosis compared to placebo. The company noted that comprehensive analyses of the data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2010.
The double-blind, placebo-controlled study involved 1,272 patients in 22 countries and assessed the efficacy, safety and tolerability of the drug. The primary endpoint of the study was reduction in annual relapse rate and the key secondary endpoint was reduction in disability progression.
The Basel, Switzerland based company said that the two-year Phase 3 study showed that oral FTY720, or fingolimod, reduced both relapses and disability progression in patients with relapsing-remitting multiple sclerosis, or MS, which is a leading cause of neurological disability in young adults.
"We are proud to have reached this critical milestone in the development of FTY720, a novel oral therapy that has the potential to transform the treatment of this ultimately disabling disease," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG.
According to Novartis, the study met its primary and secondary endpoints for both the 0.5 mg and 1.25 mg doses, with no significant difference in efficacy between doses. The results showed that FTY720 reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the 1.25 mg dose, compared with placebo. In addition, it reduced the progression of disability by 30% for patients on 0.5 mg and 32% for those on 1.25 mg, compared with placebo over two years.
在比對安慰劑服用的對照組下,服用 0.5 mg 和 1.25 mg的FTY720能夠減少54%和60%的復發率
This result builds on previous data from a one-year study showing FTY720 reduced relapses significantly more than interferon beta-1a, a standard of care treatment in MS. The one-year study showed a reduction in relapse rates of 52% and 38% for FTY720 0.5 mg and 1.25 mg respectively compared to interferon beta-1a.
在比對使用 Rebif (interferon beta-1a)服用的對照組下,服用 0.5 mg 和 1.25 mg的FTY720,能夠減少52%和38%的復發率
The company said that, the drug was well tolerated with a lower incidence of adverse events at the 0.5 mg dose than 1.25 mg and hence regulatory submissions for the drug, planned in the US and EU at the year-end, will seek approval for the lower 0.5 mg dose due to comprehensive Phase 3 results that establish its positive benefit-risk profile.
該公司表示,今年年底就會呈送美國和歐盟藥物許可(主要以0.5 mg劑量為主,因為其整體效果比較佳且安全 )
The trial is the second of three Phase 3 studies to report results in the largest development program ever conducted in MS, involving more than 4,000 patients worldwide.
According to Novartis, FTY720 has a well-studied safety profile with more than 5,300 patient-years of exposure, including patients now in their sixth year of treatment. It said that while previous data from the development program raised questions about potential side effects including macular edema, melanoma, liver injury, infections, and increased blood pressure, this study showed that at the 0.5 mg dose there were no cases of macular edema or melanoma.
初期的試驗會呈現紅疹, 水腫, 黑色腫, 肝臟損傷, 血壓生高的副作用,而後 0.5 mg劑量 不會有紅疹, 水腫, 黑色腫的副作用.
Three patients died during the study, one on FTY720 1.25 mg and two on placebo but none of the deaths were attributed to the study drug.
只有一個人在服用了 FTY720 1.25 mg的劑量而死亡.
你會選擇哪一個呢? 是Merk的治療血癌的口服藥物 "cladribine" ?
還是Novartis的口服藥 : "FTY720"?