Biogen and Sobi receive positive opinion from CHMP for Elocta(TM) (rFVIIIFc) for the treatment of Haemophilia A
(Thomson Reuters ONE) -
Biogen (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI)
received a positive recommendation from the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) for the marketing
authorisation of Elocta(TM) (rFVIIIFc). Elocta is a recombinant factor VIII Fc
fusion protein product for the treatment of haemophilia A that, if approved,
would be the first haemophilia A treatment with prolonged circulation available
in the European Union (EU).
The positive opinion was based on results from the pivotal, phase 3 A-LONG
clinical study, which examined the efficacy, safety and pharmacokinetics of
rFVIIIFc in previously treated males 12 years of age and older with severe
haemophilia A, and from the phase 3 Kids A-LONG clinical study, which evaluated
the efficacy and safety of rFVIIIFc in previously treated male children with
haemophilia A under 12 years of age. The Committee's positive opinion is now
referred to the European Commission (EC), which grants marketing authorisation
for medicines in the EU.
"The CHMP's recommendation to approve Elocta is an important milestone in
potentially bringing this innovative therapeutic option to people with
haemophilia A across Europe," said Aoife Brennan, M.D, vice president of
Hematology, Clinical Development at Biogen. "The potential of Elocta to provide
protection against bleeding episodes with fewer prophylactic infusions will, if
approved, represent the first treatment advance in nearly 20 years for Europe's
hemophilia community."
Elocta is the European trade name for rFVIIIFc, which is also known as Eloctate®
[Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada,
Australia, New Zealand and Japan, where it is approved for the treatment of
haemophilia A. Commonly reported adverse drug reactions (>/= 1% of subjects) in
the clinical studies were arthralgia, malaise, myalgia, headache and rash.
Development of Factor VIII neutralising antibodies (inhibitors) may occur
following administration of Elocta.
Biogen and Sobi are collaboration partners in the development and
commercialisation of Elocta/Eloctate for haemophilia A. Last year, Sobi
exercised its opt-in right to assume final development and commercialisation of
Elocta in the Sobi territory (essentially, Europe, North Africa, Russia and
certain countries in the Middle East). Biogen leads development for
Elocta/Eloctate, has manufacturing rights, and has commercialisation rights in
North America and all other regions in the world excluding the Sobi territory.
"We are committed to bringing meaningful treatment advances to the haemophilia
community in Europe and worldwide," said Birgitte Volck, M.D., Ph.D., senior
vice president of Development and chief medical officer of Sobi. "We welcome the
news of this positive CHMP opinion and look forward to the EC's forthcoming
Elocta decision."
- - -
About haemophilia A
Haemophilia A is a rare, chronic, genetic disorder in which the ability of a
person's blood to clot is impaired, due to missing or reduced levels of a
protein known as factor VIII. People with haemophilia A experience bleeding
episodes that may cause pain, irreversible joint damage and life-threatening
haemorrhages. According to the World Federation of Hemophilia, an estimated
140,000 people worldwide are identified as living with haemophilia A.[1]
About the A-LONG clinical study
The phase 3 A-LONG clinical study was an open-label, multi-centre study
involving 165 previously treated males 12 years of age and older with severe
haemophilia A. The study evaluated individualised and weekly prophylaxis to
reduce or prevent bleeding episodes, and on-demand dosing to treat bleeding
episodes. In the individualised arm, each study participant started on a twice-
weekly dosing regimen. Participants' pharmacokinetic parameters were used to
guide adjustments to dosing interval (every three to five days), and dose (25 to
65 IU/kg) to target a minimum factor VIII level of 1 to 3 IU/dL or higher as
needed to prevent and control breakthrough bleeding episodes. In the study, the
dose in the weekly prophylaxis arm was 65 IU/ kg/week.
About the Kids A-LONG clinical study
The Kids A-LONG study is the first clinical study to evaluate an investigational
haemophilia therapy with a prolonged half-life in children younger than 12 years
of age. The study was a global, open-label, multi-centre Phase 3 study involving
71 boys with severe haemophilia A with at least 50 prior exposure days to factor
VIII therapies.
Participants in both the A-LONG and Kids A-LONG clinical trials were able to
enrol in ASPIRE, a phase 3, open-label extension study evaluating the long-term
safety and efficacy of Eloctate. For more information about these studies,
please visit www.biogen.com.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hematologic conditions and autoimmune disorders.
Founded in 1978, Biogen is one of the world's oldest independent biotechnology
companies and patients worldwide benefit from its leading multiple sclerosis and
innovative haemophilia therapies. For product labelling, press releases and
additional information about the company, please visit www.biogen.com.
About Sobi
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on Haemophilia, Inflammation and Genetic diseases. We also market a
portfolio of specialty and rare disease products for partner companies across
Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion
(USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ
OMX Stockholm. More information is available at www.sobi.com.
For more information please contact
Sobi
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
Communications Relations
T: +46 70 410 71 80 T:
+1 347-224-0819, +1 212-579-0506, +46 8 697 2135
oskar.bosson(at)sobi.com jorgen.winroth(at)sobi.com
Biogen
Media relations Investor relations
Lee-Ann Murphy Ben Strain
+1-781-464-3260 1-781-464-2442
public.affairs(at)biogen.com IR(at)biogen.com
--------------------------------------------------------------------------------
[1] World Federation of Hemophilia. Annual Global Survey 2012.
http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed July 2015.
035e_Elocta CHMP rekommendation:
http://hugin.info/134557/R/1954568/711335.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via GlobeNewswire
[HUG#1954568]
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Datum: 25.09.2015 - 13:31 Uhr
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News-ID 422695
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