1시간전에 올라온 기사입니당 (서두에서 요약정리 ㅜㅜ)

[bamdong]

출처 : http://www.streetinsider.com/Corporate+News/Johnson+%26+Johnson+(JNJ)+Announces+FDA+Approval+of+Invega+Trinza+as+Schizophrenia+Treatment/10576267.html

교수님 이건 번역 안했어요 ㅠㅠ

제목은 " 존슨앤존슨사는 조현병 치료에 있어 인베가 트린자가 FDA의 승인을 받았다는 것을 발표했다"

그러니까 인베가 서스티나 주사가 1달용이라고 하면, 이 약은 3개월치라는 거에요.

그러니까 1년에 4번만 맞으면 1년 내내 약효가 지속된다는 거죠.

인베가가 몸에 맞으시는 분들은 희소식인거 같기도 합니다.

Johnson & Johnson (JNJ) Announces FDA Approval of Invega Trinza as Schizophrenia Treatment

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There's a new treatment option for schizophrenia – INVEGA TRINZA (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.

Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved under priority review the New Drug Application (NDA) for the three-month long-acting atypical antipsychotic INVEGA TRINZA™. INVEGA TRINZA™, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting INVEGA TRINZA™, patients must be adequately treated with INVEGA SUSTENNA? (one-month paliperidone palmitate) for at least four months. Priority review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

In a long-term maintenance trial, 93 percent of patients treated with INVEGA TRINZA™ did not experience a significant return of schizophrenia symptoms. The results of the phase 3 study were published in March by JAMA Psychiatry, a peer-reviewed medical journal published by the American Medical Association. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC).

"With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control," said trial investigator Joseph Kwentus, MD, Precise Research Centers. "Recovery looks different for everyone, and the long-term symptom control offered by INVEGA TRINZA™ can help patients work toward their own personal goals."

Schizophrenia is a complex and chronic brain disorder in which symptoms can be severe and disabling and can affect all aspects of a person's daily life. With this new treatment option, healthcare providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan.

"Building on Janssen's more than 50 years of leadership in developing innovative mental health therapies and helpful programs, this medication offers a new paradigm for treating people living with schizophrenia," said Husseini Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "After at least four months on INVEGA SUSTENNA?, patients and their doctors can seamlessly transition to INVEGA TRINZA™ for sustained symptom control with a single dose every three months."

Janssen anticipates that INVEGA TRINZA™ will be commercially available by mid-June.

"It's encouraging to see continued progress in the treatment of schizophrenia, since access to a range of treatment options is a critical success factor in the treatment journey of individuals living with this disease," said Paul Gionfriddo, president and CEO, Mental Health America. "As both an advocate and a parent of an adult son with schizophrenia, I can attest to the importance of novel therapies that enable our loved ones to spend more time focusing on their recovery and less time worrying about taking medications."

Based on the phase 3 study, the safety and tolerability profile of INVEGA TRINZA™ is consistent with that of INVEGA SUSTENNA?. No new benefit-risk concerns emerged from studies of INVEGA TRINZA™. The safety and tolerability of paliperidone has been established in multiple formulations across many clinical trials. INVEGA TRINZA™ utilizes Alkermes' proprietary NanoCrystal? technology, which enables solubility of poorly water-soluble compounds.

Over the years, Janssen has remained committed to meeting patients' needs related to their treatment. Janssen Pharmaceuticals, Inc. developed and launched JANSSEN CONNECT?, an information and assistance program designed to help patients start and stay on their Janssen long-acting injectable atypical antipsychotic after their healthcare professional has deemed it to be the most clinically appropriate treatment option. JANSSEN CONNECT? supports both INVEGA SUSTENNA? and INVEGA TRINZA™, both of which are part of the Janssen family of long-acting injectable atypical antipsychotic medications.

[bamdong]

25분전에 wall street 저널에서도 기사 나왔어요 ㅎㅎ

[보상]

약을 잘 먹지 않으려는 환우에게는 그 불편함을 다소 덜수 있으니 도움이 되겠군요.. 더 나아가 1년 또는 수년간 지속되면 더 좋으련만...

[불쏘시개]

인베가의 경우 한달치 주사제로 투여시 음성부작용이 더심각한것으로 보고되고있습니다 주사제의 편리성과 매일챙겨먹지않아도 되는 장점이있고 다른부작용들은 다른 먹는약들과 비슥하더는 명분이잇었으면 어떤식으로든 의사들은 이를 권유하고 제약회사와 협상후 주사제타입으로 변해갔을것입니다
약물의반감기를 고려한 과량의 약물투여는 분명 음성부작용의 증가를 불러올것같다는 생각이듭니다

[오리형(오산)]

자료 감사합니다.