Peginterferon β
| Peginterferon β | ||
|---|---|---|
| Mass / length primary structure | 19.241 kDa | |
| Identifier | ||
| External IDs |
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| Drug information | ||
| ATC code | L03 AB07 | |
| Drug class | Interferons | |
Peginterferon β-1a is the first PEGylated drug from the group of beta interferons . PEGylation means a binding of the active ingredient with polyethylene glycol (PEG), whereby the active ingredient is better protected against various degradation processes and thus a longer effective time is made possible. PEGylated beta interferon therefore only needs to be injected subcutaneously every two weeks . However, the active ingredient is available immediately after application . Peginterferon β-1a (trade name Plegridy ® , manufacturer Biogen ) was used in July 2014 in Europe and in August 2014 in the USA for the treatment ofMultiple sclerosis approved.
Interferons
Interferons were discovered in 1957 primarily as cellular defense substances against the spread of viral infections in tissue. Interferons have the property of strengthening a defense reaction of the body against some viral infections through unspecific stimulation of the T lymphocytes . Today, in addition to the antiviral properties, the anti-tumor effect is in the foreground of therapeutic interest.
As drugs of first choice for basic therapy for relapsing forms of multiple sclerosis (MS) are beta-interferons used.
Benefits of PEGylation
Peginterferon α -2b was the first pegylated interferon on the market and was approved under the product name PegIntron ® . In the meantime there are several different peginterferon-α variants and also some other pegylated drugs, e.g. B. Mircera ® (manufacturer Roche ) and Neulasta ® (manufacturer Amgen ).
PEGylation increases the molecular weight of the active ingredient and can imply some significant pharmacological advantages over the unmodified active ingredient:
- increased drug solubility
- Extension of the periods between the application of the active ingredient without reducing the efficiency and usually with fewer toxic side effects
- extended residence time in the patient's body
- increased drug stability
- better protection against degradation by proteases
Commercially, PEGylation also has advantages. In addition to the development of more patient-friendly dosage forms and dosages, the patent terms of older active substance patents can also be extended through new patents.
Studies
Peginterferon β-1a
In April 2014, the results of the so-called ADVANCE study, which form the basis for the approval application, were presented at the Annual Meeting of the American Academy of Neurology . The two-year Phase III study was a global, multicenter , randomized , double-blind , parallel-group, placebo- controlled study designed to evaluate the efficacy and safety of Plegridy ® in 1,516 patients with MS. The study looked at two doses of Plegridy ® : 125 µg subcutaneously every two weeks or every four weeks compared to placebo. Plegridy ® - applied subcutaneously once every two weeks - achieved all primary and secondary endpoints for a significant reduction in disease activity, including relapses and disability progression, and demonstrated a favorable safety and tolerability profile after one and two years.
literature
- PA Calabresi: Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomized, phase 3, double-blind study . In: The Lancet Neurology . May 2014, doi : 10.1016 / S1474-4422 (14) 70068-7 .
Web links
- Positive study results from the phase III study on peginterferon beta-1a in multiple sclerosis , journalMED of February 19, 2013, accessed on May 8, 2014
- Peginterferon in multiple sclerosis: As good as interferons according to the ADVANCE study , Medscape Deutschland Neurologie from April 19, 2013, accessed on May 1, 2014
- New Data from Plegridy (pegylated interferon beta-1a) Phase 3 Trial Shows Improved Recovery from Relapses , MultipleSclerosis.net, accessed May 12, 2014
Individual evidence
- ↑ Product Pipeline ( Memento of the original from May 4, 2011 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , accessed on May 1, 2014 from the global website.
- ↑ Biogen Idec Receives Notification of PDUFA Date Extension for Plegridy ™ (Peginterferon Beta-1a) ( Memento of the original from May 2, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen Idec PM on March 18, 2014, accessed May 1, 2014.
- ↑ a b Biogen Idec to Present New Two-Year Data from the PLEGRIDY ™ (Peginterferon Beta-1a) Phase 3 ADVANCE Study at AAN Annual Meeting ( Memento of the original from May 2, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen Idec PM on April 29, 2014, accessed May 1, 2014.
- ↑ PLEGRIDY ™ (peginterferon beta-1a) Approved in the European Union for the Treatment of Multiple Sclerosis ( Memento of the original from April 8, 2014 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen Idec PM on July 23, 2014, accessed July 24, 2014.
- ↑ Biogen Idec's PLEGRIDY ™ (Peginterferon Beta-1a) Approved in the US for the Treatment of Multiple Sclerosis ( Memento of the original dated September 11, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen Idec PM on August 15, 2014, accessed August 18, 2014.
- ↑ Alick Isaacs , Jean Lindenmann : Virus Interference. I. The interferon . In: Proceedings of the Royal Society of London. Series B - Biological Sciences . tape 147 , no. 927 , December 9, 1957, pp. 258-267 , doi : 10.1098 / rspb.1957.0048 .
