Date: 2016-04-21
Type of information: Granting of a patent
Product name: Kineret®
Compound: anakinra
Therapeutic area: Rare diseases - Inflammatory diseases - Immunological diseases
Action mechanism: protein. Kineret® (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and driver of autoinflammatory diseases in both adults and children.
Company: Swedish Orphan Biovitrum (Sobi) (Sweden)
Disease: Cryopyrin-Associated Periodic Syndromes (CAPS):
neonatal-onset multisystem inflammatory disease (NOMID)
Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
Muckle-Wells Syndrome (MWS)
Familial Cold Autoinflammatory Syndrome (FCAS)
Latest news: * On August 19, 2015, Swedish Orphan Biovitrum (Sobi) together with its Australian partner, A. Menarini Australia Pty Ltd received marketing authorisation in Australia for Kineret® (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA). * On November 20, 2013, Swedish Orphan Biovitrum (Sobi) has announced that the European Commission (EC) has approved Kineret® (anakinra) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2013. This approval was based on the outcome of a long-term safety and efficacy study in children and adults with the most severe form of CAPS called Neonatal-Onset Multisystem Inflammatory Disease (NOMID), or Chronic Infantile Neurologic Cutaneous and Arthritis syndrome (CINCA). The study was conducted at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH) in Bethesda, MD, USA. * On September 19, 2013, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an extension application for the Marketing Authorisation for the medicinal product Kineret® to add a new strength 100mg/0.67 ml solution for injection in a pre-filled syringe for a new indication in adult and paediatric patients for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The prefilled syringe also allows the administration of the approved dosage required in patients with rheumatoid arthritis. The approved indications for this new strength are as follows: Kineret® is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in adults with an inadequate response to methotrexate alone. Kineret® is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), Muckle-Wells Syndrome (MWS), Familial Cold Autoinflammatory Syndrome (FCAS). The opinion is based on a positive benefit risk assessment of the results from a long-term treatment study in children and adults with NOMID/CINCA, the most severe form of CAPS. In December 2012, Kineret® became the first and only FDA-approved therapy for NOMID/CINCA. Sobi will provide Kineret® for home treatment in a prefilled syringe with a graduated label to allow flexible dosing in children. * On June 6, 2013, Swedish Orphan Biovitrum (Sobi) has announced receipt of approval from the FDA for the manufacture of drug substance for Kineret® (anakinra) at Boehringer Ingelheim's microbial site in Vienna, Austria. The approval allows for distribution of Kineret® in the US, and comes as the result of a Supplemental Biologics License Application (sBLA) filed with the FDA in February 2013. * On January 23, 2013, Sobi has announced receipt of approval from the European Medicines Agency (EMA) for the manufacture of drug substance for Kineret® (anakinra) at Boehringer Ingelheim's microbial site in Vienna, Austria. The approval allows for distribution of Kineret® to EMA territory countries, and comes as the result of an application filed with the EMA in October of 2012. A similar application has been filed with the US FDA and authorities in other countries where Kineret® is approved. * On January 8, 2013, Swedish Orphan Biovitrum has announced that the FDA has approved Kineret® (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). Kineret® is the first and only FDA-approved therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS). Kineret® was approved for NOMID under an Orphan Drug designation. A priority review was granted by the FDA based on the product's potential to provide a significant advance in therapy for the NOMID patient population where no adequate therapy exists. Sobi will provide a prefilled syringe with a graduated label to allow flexible dosing in children. Kineret® has been approved for the reduction of signs and symptoms of rheumatoid arthritis (RA) in adults since 2001. Swedish Orphan Biovitrum looks forward to making Kineret more widely available to patients with NOMID in the United States this year. * On November 19, 2012, Swedish Orphan Biovitrum has announced that it has filed an application for an EU Marketing Authorization with the EMA for Kineret® (anakinra) for the indication of cryopyrin associated periodic syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe form of CAPS. The EMA filing follows the filing for Kineret for NOMID with the US Food and Drug Administration (FDA) in July 2012, which has been granted priority review with an expected approval date of 25 December 2012. * On July 6, 2012, Swedish Orphan Biovitrum has announced that it has filed an application for Kineret® (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID) with the FDA. The filing is made under an Orphan Drug Designation for the indication cryopyrin associated periodic syndromes (CAPS), which was granted in 2010. If the application is granted priority review, Sobi expects a review period of 6-8 months. The basis for the filing is a clinical trial initiated and conducted by Principal Investigator Dr Raphaela Goldbach-Mansky at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at NIH in Bethesda, MD. The trial which includes a majority of NOMID patients in the US has gathered extensive long-term treatment data.
Patents: * On April 21, 2016, Swedish Orphan Biovitrum announced that the company has been granted a patent (EP2672985) in Europe for a new, citrate free formulation for Kineret® (anakinra). The European Patent Office (EPO) will publish the patent on 27 April 2016 and the patent will be validated in all available contracting states of the EPO. The patents will expire in February 2032. A corresponding US patent (9,198,954) was granted on 1 December 2015.
Submission of marketing authorization application USA : 2012-07-06
Submission of marketing authorization application UE: 2012-11-19
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-12-00
UE authorization: 2013-11-20
Favourable opinion UE: 2013-09-19
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
