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Di, 14.03.2017 14:00
pts20170314029 Health/Medicine, Products/Innovations
AOP Orphan starts EMA marketing authorization application procedure for Ropeginterferon alfa-2b
Vienna (pts029/14.03.2017/14:00) - AOP Orphan Pharmaceuticals AG announces start of EMA marketing authorization application procedure for Ropeginterferon alfa-2b in Polycythemia Vera
* EMA started the centralized marketing authorization procedure for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) on Feb 23rd 2017.
* Ropeginterferon alfa-2b is a novel mono-pegylated interferon with an improved every-two-week application schedule and orphan designation in Europe and the U.S.
* AOP´s development program in PV consistently demonstrated convincing efficacy, safety, tolerability, convenience and compliance.
* Data from AOP´s development program will be presented to U.S. FDA for approval for commercialization in the U.S. by PharmaEssentia.
* PharmaEssentia discovered Ropeginterferon alfa-2b and exclusively licensed the development and commercialization rights for myeloproliferative neoplasms in Europe, CIS and Middle Eastern markets to AOP Orphan.
AOP Orphan Pharmaceuticals AG (AOP Orphan) announced the start of the EMA marketing authorization application procedure (centralized procedure) for the European licensure of Ropeginterferon alfa-2b in Polycythemia Vera (PV) on Feb 23rd 2017.
Ropeginterferon alfa-2b, a novel, long-acting, mono-pegylated proline interferon, uniquely administered once every two weeks, is expected to be the first interferon approved for PV worldwide and the only approved first-line treatment for PV in the U.S. The drug has an orphan designation in both Europe and the U.S.
Key results from AOPs development program in PV have been announced earlier:
In the ongoing phase II trial PEGINVERA patients have been treated with Ropeginterferon alfa-2b for up to over 5 years, showing convincing efficacy and tolerability. Notably, all remaining patients are maintained on a convenient once-a-month dosing regimen.
In the phase III trial PROUD-PV, Complete Hematologic Response (CHR) was achieved in a high proportion of patients and non-inferiority to hydroxyurea (HU) was demonstrated (43.1% for Ropeginterferon alfa-2b versus 45.6% for HU in the intent-to-treat-population, p=0.0028) at 12 months. Ropeginterferon alfa-2b showed significantly better tolerability than HU. The ongoing phase III extension study CONTINUATION-PV will add long-term data.
Importantly, interferons are the only known treatment modality with the potential for disease modification, which is believed to improve progression-free survival and long-term outcomes.
Professor Heinz Gisslinger from the Medical University of Vienna, the principal investigator in AOP´s development program said, "Interferons have been used successfully in myeloproliferative neoplasms for over 30 years, now Ropeginterferon alfa-2b is expected to be the first interferon to be licensed in these indications. Study data confirm the expected efficacy, while safety and tolerability appear superior in comparison to previously reported data on other interferons."
"AOP Orphan has continuously invested over many years into development of treatments in the field of MPNs. The successful validation of the centralized marketing authorization procedure in Europe via EMA for Ropeginterferon alfa-2b as an orphan designated medicine is a further milestone in our long term commitment to providing drugs for patients with rare diseases," said Rudolf Widmann, Ph.D. founder and CEO of AOP Orphan.
Ko-Chung Lin, Ph.D., founder and CEO of PharmaEssentia, added, "PharmaEssentia has successfully developed the technology to drive long-acting interferon beyond the weekly dosing regimen. The advantages provided by Ropeginterferon alfa-2b, apparent by its promising Phase III data and prior studies, along with our state-of-the-art manufacturing facility in Taiwan, collectively bring us closer to offer efficacious and safe therapies for the treatment of myeloproliferative neoplasms such as PV, myelofibrosis, chronic myeloid leukemia, as well as hepatitis and other diseases."
About Ropeginterferon alfa-2b
About Polycythemia Vera
About AOP Orphan Pharmaceuticals AG