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ÁöµM¥»¨Ó´N¤£¬O¤@ӫ¯Ù, ²{¦b¤j®a¤£¥Î¾á¤ßJakafi ·|·m¹PV¥«³õ¤F¡ã Incyte¡¦s Jakafi Fails to Provide RELIEF in Polycythemia Vera Zacks By Zacks Equity Research 4 hours ago Incyte Corporation (INCY) announced disappointing top-line results from the phase III RELIEF study (n=110) on Jakafi in the polycythemia vera (PV.V) indication. The RELIEF study is evaluating PV patients treated with Jakafi in comparison to those being treated with hydroxyurea. Results revealed that a significant proportion of patients treated with Jakafi failed to achieve more than 50% reduction in a defined cluster of symptoms including tiredness, itching, muscle aches, night sweats and sweats while awake at week 16 from baseline. Consequently the study did not meet its primary endpoint. Jakafi treated patients managed to show a 43.4% symptom response rate compared to a symptom response rate of 29.6% in the hydroxyurea arm. Last month, the company had submitted a supplemental New Drug Application (sNDA) for Jakafi in the U.S. for the PV indication based on positive results from the RESPONSE study also announced in June. (Read more: Incyte Gains on Positive Jakafi Data). Incyte stated that if approved, Jakafi will be the first JAK1/JAK2 inhibitor to be available for patients suffering from PV. We note that Jakafi was launched in the U.S. in Nov 2011 for treating patients suffering from intermediate or high-risk myelofibrosis (:MF). Jakafi contributed around $69.7 million to Incyte¡¦s top line in the first quarter 2014, representing an increase of 44% from the year-ago quarter. |
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·|û¡G¤p^10137462 µoªí®É¶¡:2014/7/23 ¤U¤È 04:21:53²Ä 4 ½g¦^À³
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·|û¡GDesert10136931 µoªí®É¶¡:2014/7/22 ¤W¤È 10:57:09²Ä 3 ½g¦^À³
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Linsanity ³Á¼w©i»ä·µn³°¤F¡A¥xÆW¥Í§Þ¬É¦ü¥G¤]±N¦³µÛ½¤ÑÂЦaªº§ïÅÜ¡I ¤@¤Á±qªL®Ñ»¨½Í°_¡C ³ÌªñªL®Ñ»¨¤@ªð°ê®É¡A¦ü¥GÄx²y´N¬O¥L¬°¥Nªí¡A ¬Ý°_¨Ó°ê¤º¥´²yªº¡uª¾¦W¤Hª«¡v³£®ø¥¢¡A¥L¬O´CÅ骺Ãd¨à¡B«C¤Ö¦~ªº°¸¹³¡C ³o¬O¦]¬°¥L¬OµØ¤Hªº±¤Õ¡A¯à¦bÄx²yªº³Ì°ª·µ°ó-NBA¹£Áþ¡C ¥Í§Þ¬É¤§FDA¡A´N¦p¦PÄx²yNBA¤@¼Ë¡A¯à¤WFDA¤~¯àµn¤W¥Í§Þªº³Ì°ª·µ°ó¡I ³o¬O¦]¬°ÂåÀø¥«³õ¡A¬ü°ê¥e¤F¥þ²yªº4¦¨¡A¼Ú¬w3¦¨¡CÅý¤j®aÁͤ§Yõ¡I ¦ý¬O³o¤@¶ô¡A¦ü¥G³£¬O¥Õ¤Hª±ªº¤Ñ¤U¡C ªL®Ñ»¨©è¥x¡A¤]±a¨Ó¥Í§Þ¬É¡uªL¨ÓºÆ¡vªº¬ð¯}¡I ³o¬O¥xÆW¦³¥v¥H¨Ó¡A²Ä¤@¦¸¥xÆW¤½¥q¯à¥H¦Û¤v¦W¸q¡A¯à¤WFDA²Ä¤T´Á¡C °£¤FÃĵءA³Ìªñ´X¦~¤º¡A§Ṳ́]¼Ö¨£¦³µÛ²Ä¤GÓLinsanity ¯àÅD¤W°ê»Ú»R¥x¡I |
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·|û¡G·¥¥ú10138185 µoªí®É¶¡:2014/7/22 ¤W¤È 09:41:41²Ä 2 ½g¦^À³
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