Patient taking Novartis MS pill developed rare disease
로이터통신 Tue Jul 30, 2013 2:48pm IST
http://in.reuters.com/article/2013/07/30/novartis-gilenya-idINL6N0G02A52013073
* Patient took Novartis’ Gilenya MS pill
* Developed progressive viral disease
* First incidence in 71,000 patients
* Gilenya facing competition from Biogen’s Tecfidera
ZURICH, July 30 (Reuters) – A patient taking Novartis’ multiple sclerosis pill Gilenya developed a rare and potentially fatal viral disease, the Swiss drugmaker said on Tuesday, an unexpected setback as it faces growing competition from new oral treatments.
Gilenya is one of Novartis’ big new drug hopes, growing 66 percent in the second quarter to $468 million. But the drug faces competition from new medicines such as Biogen Idec’s Tecfidera.
Novartis said it had been informed of a case of progressive multifocal leukoencephalopathy (PML) in a patient who had been taking Gilenya for MS for seven months.
It said it was working with the reporting physician to understand all possible contributing factors, including those beyond treatment, given several atypical features of the case.
“The course of the underlying neurological disease was rapid with some atypical findings for MS on the MRI scans of the brain and spinal cord, as well as some unusual clinical features,” Novartis said in a statement.
Novartis said all previously reported cases of PML among the approximately 71,000 patients treated with Gilenya thus far had been attributed to prior treatment with Biogen Idec’s Tysabri, which bears a known risk of PML.
Deutsche bank analyst Tim Race said the case may provoke some concerns about Gilenya’s future growth potential. But he noted the incidence of reported PML cases for Gilenya has so far been extremely low.
“By the time there was a similar level of patient experience with Tysabri there had been 298 cases reported. Thus, even if the risk proves to be real it is likely to be of a very different order of magnitude,” Race said in a note.
Shares in Novartis were trading down 0.8 percent at 66.10 Swiss francs by 0904 GMT, compared to a 0.4 percent weaker European healthcare sector.
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노바티스 ‘길레니아’ 복용자, PML 발생 보고
치명적 바이러스 질환.. 발생 원인 조사 중
데일리팜 2013-07-31 08:05:57
http://www.dailypharm.com/Users/News/NewsView.html?ID=173758
노바티스는 다발성 경화증 치료제인 ‘길레니아(Gilenya)’를 복용한 환자에서 드물고 잠재적으로 치명적인 바이러스 질환이 발생했다고 30일 밝혔다.
길레니아는 노바티스가 기대하는 약물 중 하나. 그러나 바이오겐의 ‘텍피데라(Tecfidera)’와 경쟁으로 영향이 있을 것으로 전망된다.
노바티스는 7개월간 길레니아를 복용한 환자에서 진행성 다소성 백질뇌염(progressive multifocal leukoencephalopathy, PML)이 발생했다고 말했다.
현재 노바티스는 치료제를 포함해 질병의 발생 원인이 될 수 있는 모든 인자에 대해 조사를 벌이고 있는 중이라고 말했다.
지금까지 노바티스는 길레니아로 치료를 받던 7만1000명 중 PML이 발생이 보고된 경우는 PML 위험성이 있는 ‘티사브리(Tysabri)’로 이전에 치료를 받았기 때문이라고 설명해왔다.
분석가들은 길레니아의 부작용에 대한 우려가 입증될 경우 길레니아의 성장세가 정체될 수 있다며 우려를 나타냈다.
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