默克藥廠向歐盟申請核准多發性硬化症的口服藥物上市

默克藥廠向歐盟申請核准多發性硬化症的口服藥物上市
Merck KgaA Asks EU to Approve Multiple Sclerosis Pill (Update1)

July 23 (Bloomberg) -- Merck KGaA asked European regulators to approve its pill for multiple sclerosis, the next step in the German drugmaker’s race against Novartis AG to market the first oral medicine for the debilitating nerve disease.

同時還有另外一家藥廠Novartis AG 也有同樣的動作, 兩家在競爭誰會成為歐洲第一家MS口服藥物的上市.

Merck submitted a marketing authorization application for the pill, cladribine, to the European Medicines Agency and plans an application to U.S. regulators this quarter, the Darmstadt, Germany-based maker of drugs and chemicals said in an e-mailed statement today.'

默克藥廠的多發性硬化症的口服藥 名稱是: cladribine

Novartis 藥廠的多發性硬化症的口服藥 名稱是: FTY720

The application “brings us closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis,” Roberto Gradnik, an executive vice president in Merck’s Serono division, said in the statement.

Merck presented clinical trial data at the American Academy of Neurology conference in April showing that cladribine halved the risk of relapse, with a side effect in some patients of depleting the white blood cells that protect the body from infection. Patients who took cladribine were less likely to see their multiple sclerosis progress and more likely not to relapse at all than those on a placebo, the two-year trial showed.

Five people were diagnosed with cancer, including one case of choriocarcinoma, a cancer of the placenta, in a woman who became pregnant six months after she finished the study.

Unlike existing injected medicines for multiple sclerosis, cladribine, approved to fight leukemia more than a decade ago, is taken for a few weeks out of the year in pill form. The medicine works by suppressing the immune system, blunting its attack on nerve cells. Merck’s pill could compete with an experimental pill from Novartis, FTY720, which disrupts the movement of immune cells into the bloodstream.

cladribine 是一種已經核准用來治療白血病(血癌)的藥物, 此藥物藉由壓制免疫系統來避免免疫系統攻擊神經系統的結果, 其結果能夠和FTY720的實驗結果相比擬. 能夠降低MS發作幾乎達到一半的機率, 其副作用是造成血液中白血球的降低

而FTY720主要的作用是破壞或避免免疫細胞進入血液當中(或者是將進入血液當中的免疫細胞予以破壞分解).

感覺上不是和免疫抑制劑 Immuran 有點像嗎? 都會降低白血球的數目... ^^|||

默克藥廠向歐盟申請核准多發性硬化症的口服藥物上市