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Pts on Hydroxyurea 57567 61485

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2018/12/18 ¤U¤È 10:03:39²Ä 5656 ½g¦^À³
Breaking news for ropeginterferon

www.mpnresearchfoundation.org/

Breaking news for ropeginterferon: CHMP (The Committee for Medicinal Products for Human Use; European Medicines Agency¡¦s committee responsible for elaborating the agency¡¦s opinions on all issues regarding medicinal products for human use) has given a positive opinion on the drug and recommended granting market authorization. If approved, this will be the first time an interferon has been developed specifically for MPN. Many patients use a version of interferon off-label now, but there is doubt about supply and access for patients globally as the manufacturer of at least one version widely taken - Pegasys - has declined so far to seek approval for its use in myeloproliferative neoplasms.

The drug will be called Besremi, at least in the European market. Pharmaessentia is also talking to FDA about approval in the US.

We are excited about the opportunity to give more people with MPN access to medications that can help them live longer, healthier lives. We will keep you up to date with the latest on this and any other drug or research news for PV, ET and MF.

Ãö©óropeginterferonªº³Ì·s®ø®§¡GCHMP¡]¤H¥ÎÃÄ«~©e­û·|;¼Ú¬wÃÄ«~ºÞ²z§½­t³d¸Ô²ÓÄÄ­z¸Ó¾÷ºc¹ï¤H¥ÎÂåÃIJ£«~©Ò¦³°ÝÃDªº·N¨£ªº©e­û·|¡^¹ï¸ÓÃĪ«µ¹¤©¤F¿n·¥ªº·N¨£¡A¨Ã«Øijµ¹¤©¥«³õ±ÂÅv¡C¦pªGÀò±o§å­ã¡A³o±N¬O²Ä¤@¦¸±Mªù¬°MPN¶}¾v°®ÂZ¯À¡C³\¦h±wªÌ²{¦b¨Ï¥Î¤@ºØ¤zÂZ¯À¼ÐÅÒ¡A¦ý¥þ²y±wªÌªº¨ÑÀ³©MÀò¨ú¦s¦bºÃ°Ý¡A¦]¬°¦Ü¤Ö¦³¤@­Ó¼sªx±Ä¥Îªºª©¥»--Pegasys--ªº»s³y°Ó¨´¤µ¬°¤î¤w¸g©Úµ´§å­ã¨ä¦b°©Åè¼W¥Í©Ê¸~½F¤¤ªº¨Ï¥Î¡C

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.....[Looking at the longer term, Trogarzo peak sales could be 5 times or more than those of EGRIFTA.]

So we believe that such objectives are both achievable and realistic. Some may have found that because Trogarzo is an exceptional life saving treatment, that sales will reach their peak overnight...............]

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6.5 ´Á«ÝQ1¼Ú¬w¥¿¦¡ÃÄÃÒ, »P¬ü°êÃÄÃÒ±µ¤U¨Ó«ç»ò¥Ó½Ð......½×³z©ú«×»P¥»·~ªº±Mª`»P¥Î¤ß,¦³·P¤pµØ¤w¸gºâ«Üí²Ïí¥´¤F, Gºô§O¶Ã¤H¤ß, ¤pµØºÞ²z¶¥¼h»P¹Î¶¤³o¬q®É¶¡¤@©w«D±`«D±`«D±`¦£¸L....

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How one patient persuaded her company to pay for Pegasys

www.mpnresearchfoundation.org/Pegasys-appeal-3A-one-patient-27s-story

CHMP Recommended Granting Marketing Authorization for Ropeginterferon

www.mpnresearchfoundation.org/CHMP-Recommended-Granting-Marketing-Authorization-for-Ropeginterferon

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Physicians experienced in the management of the disease and administration of BESREMi® during the clinical studies expect many advantages for the patients with PV.¡¨¡¦¡¦

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2018/12/15 ¤U¤È 11:35:04²Ä 5577 ½g¦^À³
Polycythemia Vera: From New, Modified Diagnostic Criteria to New Therapeutic Approaches

Margherita Maffioli, MD, Barbara Mora, MD, and Francesco Passamonti, MD

Clinical Advances in Hematology & Oncology Volume 15, Issue 9 September 2017

PV is characterized by erythrocytosis and, in approximately 40% of patients, some degree of leukocytosis and

thrombocytosis. Splenomegaly occurs in 30% of cases and is rarely massive.

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Enlarged spleen (splenomegaly)¡X¡X¡XYour spleen helps your body fight infection and filter unwanted material, such as old or damaged blood cells. The increased number of blood cells caused by polycythemia vera makes your spleen work harder than normal, which causes it to enlarge.

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·PÁÂ543¤j´£¨Ñ¸ê°T¡C

Current and future treatment options for polycythemia vera

Martin Griesshammer & Heinz Gisslinger& Ruben Mesa

Additionally, approximately 35 to 45 % of patients may develop splenomegaly,

although its presence is usually indicative of advanced disease¡C

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¤]³\°ÝÃD¤£¦b¦³¨S¦³splenomegaly

¤]³\¬O¦b¡¨without symptomatic¡¨

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²q·Q¤j¡A

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2016¦~µoªí©óJournal of Clinical Oncology¦³¤@½gPV¯gª¬¯S¼xªº¤ÀªR½×¤å¡A

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ascopubs.org/doi/10.1200/JCO.2015.62.9337

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link.springer.com/content/pdf/10.1007/s00277-015-2357-4.pdf

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EMA³q¹Lªº¾AÀ³¯g¬°[without symptomatic splenomegaly] , ¨Ï¥Î½d³ò¨ü¨ì­­ÁY

¤p§Ì¬Ý¨ì¿D¬wLeukaemia Foundationªº¸ê®Æ

www.leukaemia.org.au/disease-information/myeloproliferative-disorders/types-of-mpn/polycythemia-rubra-vera/

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Enlargement of the spleen (splenomegaly) is also common and occurs in around 75 per cent of cases.

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¤ñ[without symptomatic splenomegaly]§ó­«­nªº¬O¡AProud/Conti-PVªº¯f¤H¦¬¯Ç±ø¥ó¤§¤@¬O[For previously cytoreduction untreated patients - documented need of cytoreductive treatment]¡A¦]¦¹§Ú­ì¥»¹w´Á¾AÀ³¯gÀ³¸Ó¬Oµ¹[high risk polycythaemia vera]¡A¥¼¨Ó»Ý­n¦A°w¹ïlow risk¯f¤H¶i¦æ¸É¥R©Ê¸ÕÅç«á¥Ó½Ðlabel extension¡Aµ²ªGEMAµ¹ªºµ²ªG³ºµM¤£­­©w©óhigh risk! (³o¼W¥[²[»\ªº±Ú¸s·|¤ñwithout symptomatic splenomegaly©Ò´î¤Öªº±Ú¸sÁÙ¦h) ¹L¥h¼Ú¬w³\¦hÂå®v°w¹ïlow risk¯f¤HÁÙ¬O±Ä¨ú®ø·¥ªºwatch and wait©Î©ñ¦å¡ABesremiÃÄÃÒ¤£­­©whigh/low risk¯f¤H¡A¦³¾÷·|Åý§ó¦hÂå®v±Ä¨ú¿n·¥ªºªvÀøµ¦²¤¡C

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www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-

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13-december-2018

EMA¡¦s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting.

Two orphan medicines1 received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.

The CHMP recommended granting a marketing authorisation for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.

Rizmoic (naldemedine) received a positive opinion for the treatment of opioid-induced constipation.

The Committee granted a positive opinion for Tobramycin PARI (tobramycin), a hybrid medicine for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data.

The biosimilar medicine Zirabev (bevacizumab) received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix.

The Committee recommended for approval the generic medicine Miglustat Dipharma (miglustat), for the treatment of adult patients with mild to moderate type 1 Gaucher disease.

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

News 14/12/2018

EMA¡¦s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting.

Two orphan medicines1 received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly,

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www.chinatimes.com/newspapers/20181212000458-260206

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www.ema.europa.eu/en/medicines/human/summaries-opinion/besremi

Besremi

ropeginterferon alfa-2b

Opinion

On 13 December 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Besremi, intended for the treatment of polycythaemia vera without symptomatic splenomegaly. Besremi was designated as an orphan medicinal product on 9 December 2011. The applicant for this medicinal product is AOP Orphan Pharmaceuticals AG.

Besremi will be available as a solution for injection (250 microgram/0.5 ml and 500 microgram /0.5 ml). The active substance of Besremi is ropeginterferon alfa-2b (ATC code:L03AB15), which inhibits the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonises the action of growth factors and other cytokines involved in the development of myelofibrosis.

The benefits with Besremi are its ability to achieve complete haematological responses in patients with polycythaemia vera. The most common side effects are leucopenia, thrombocytopenia, arthralgia, fatigue, flu-like illness and myalgia.

The full indication is: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. It is proposed that Besremi is prescribed by physicians experienced in the management of the disease.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

www.ema.europa.eu/en/medicines/human/summaries-opinion/besremi

Besremi

ropeginterferon alfa-2b

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2018¦~12¤ë13¤é¡A¤H¥ÎÃÄ«~©e­û·|¡]CHMP¡^±Ä¯Ç¤F¿n·¥ªº·N¨£¡A«Øij±Â¤©BesremiÃÄ«~ªº¤W¥«³\¥i¡A¥Î©óªvÀø¨S¦³¯gª¬©ÊµÊ¸~¤jªº¬õ²Ó­M¼W¦h¯g¡C Besremi©ó2011¦~12¤ë9¤é³Q«ü©w¬°©t¨àÃÄ«~¡C¸ÓÃÄ«~ªº¥Ó½Ð¤H¬OAOP Orphan Pharmaceuticals AG¡C

Besremi±N§@¬°µù®g²G´£¨Ñ¡]250·L§J/0.5²@¤É©M500·L§J/0.5²@¤É¡^¡C Besremiªº¬¡©Êª«½è¬Oropeginterferon alfa-2b¡]ATC¥N½X¡GL03AB15¡^¡A¨ä§í»s³y¦å²Ó­M©M°©Å覨ÅÖºû²Ó­M¯ª²Ó­Mªº¼W´Þ¡A¨Ã«ú§Ü¥Íªø¦]¤l©M°Ñ»P°©ÅèÅÖºû¤Æµo®iªº¨ä¥L²Ó­M¦]¤lªº§@¥Î¡C

Besremiªº¦n³B¬O¥¦¯à°÷¦b±w¦³¬õ²Ó­M¼W¦h¯gªº±wªÌ¤¤¹ê²{§¹¥þªº¦å²G¾Ç¤ÏÀ³¡C³Ì±`¨£ªº°Æ§@¥Î¬O¥Õ²Ó­M´î¤Ö¯g¡A¦å¤pªO´î¤Ö¯g¡AÃö¸`µh¡A¯h³Ò¡A¬y·P¼Ë¯e¯f©M¦Ùµh¡C

§¹¾ã¾AÀ³¯g¬O¡GBesremi¾A¥Î©ó¦¨¤H³æÃĪvÀø¡A¥Î©óªvÀøµL¯gª¬©ÊµÊ¸~¤jªº¬õ²Ó­M¼W¦h¯g¡C«ØijBesremi¥Ñ¦b¯e¯fºÞ²z¤è­±¸gÅçÂ×´IªºÂå¥Í¶}³B¤è¡C

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www.ema.europa.eu/en/medicines/human/summaries-opinion/besremi

Besremi

ropeginterferon alfa-2b

Opinion

On 13 December 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Besremi, intended for the treatment of polycythaemia vera without symptomatic splenomegaly. Besremi was designated as an orphan medicinal product on 9 December 2011. The applicant for this medicinal product is AOP Orphan Pharmaceuticals AG.

Besremi will be available as a solution for injection (250 microgram/0.5 ml and 500 microgram /0.5 ml). The active substance of Besremi is ropeginterferon alfa-2b (ATC code:L03AB15), which inhibits the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonises the action of growth factors and other cytokines involved in the development of myelofibrosis.

The benefits with Besremi are its ability to achieve complete haematological responses in patients with polycythaemia vera. The most common side effects are leucopenia, thrombocytopenia, arthralgia, fatigue, flu-like illness and myalgia.

The full indication is: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. It is proposed that Besremi is prescribed by physicians experienced in the management of the disease.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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