Europeiska läkemedelsmyndigheten accepterar ansökan för marknadsföring av naloxegol

fredag, 27 september 2013

AstraZeneca meddelar idag att den europeiska läkemedelsmyndigheten (EMA) har accepterat ansökan för marknadsföring (MAA) av naloxegol, en substans under utveckling som är en perifer my-opioidreceptorantagonist, särskilt utvecklad för behandling av patienter med förstoppning orsakad av opioider (opioid-induced constipation, OIC) hos vuxna från 18 år, inklusive patienter med otillräckligt svar på behandling med laxativ.

Ansökan om godkännande baserades på omfattande data från det centrala prövningsprogrammet i fas 3, KODIAC, som bestod av fyra kliniska studier för att fastställa säkerhet och effekt hos naloxegol vid behandling av OIC. Vid två randomiserade, dubbelblinda och placebokontrollerade studier i fas 3, KODIAC-04 (n=652) och KODIAC-05 (n=700), som båda pågick i 12 veckor, utvärderades naloxegol i doserna 12,5 mg respektive 25 mg vid oral tillförsel en gång dagligen. KODIAC-07 var en 12 veckors förlängning av KODIAC-04 för ytterligare säkerhetskontroll, och KODIAC-08 (n= 534) var en öppen, randomiserad säkerhetsinriktad långtidsstudie under 52 veckor.

Naloxegol har potential att bli det första läkemedlet för oral tillförsel en gång dagligen, med perifer verkan som antagonist mot my-opioidreceptorn, för behandling av OIC. Naloxegol har utvecklats med hjälp av Nektars teknologi för småmolekylsläkemedel baserade på polymerkonjugat.

Naloxegol omfattas av det globala licensavtal med ensamrätt mellan AstraZeneca och Nektar Therapeutics som tillkännagavs den 21 september 2009. Enligt villkoren i detta nyligen modifierade avtal ska AstraZeneca göra en delbetalning på 25 miljoner USD till Nektar, inom fem vardagar efter EMA:s godkännande av MAA.

NOTES TO EDITORS

About Opioid-Induced Constipation

OIC is a condition caused by prescription opioid pain medicines. Opioids bind to specific proteins called opioid receptors. When the opioids bind to certain opioid receptors in the gastrointestinal (GI) tract, constipation may occur. Opioid-induced constipation is a result of increased fluid absorption and lower GI motility due to opioid receptor binding in the gastrointestinal tract.

Globally, approximately 40–50% (28-35 million) of patients taking opioids for long-term pain develop opioid-induced constipation. About 40–50% (11-18 million) of those OIC sufferers achieve the desired treatment outcomes with current options that include over-the-counter and prescription laxatives.

About Nektar

Nektar Therapeutics (NASDAQ: NKTR) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has completed Phase 3 development as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic candidate for chronic pain conditions, is in Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian and colorectal cancers. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare to treat patients with Gram-negative pneumonia.

Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development.

Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

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