by Catherine Hinz
In connection with an interesting discussion on the appropriateness of the use of Avastin in the treatment of AMD, which fulfilled our profile on Facebook, we decided to start a new cycle on pharmacology entitled “In a nutshell”. We will from time to time to mark the drugs used in ophthalmology and which affects the use of the visual system.
Mentioned in the previous entry on foropter.pl two most commonly used pharmacological agents for the treatment of AMD. These are Avastin and Lucentis . Avastin is used to treat AMD for several years, but this is the use of a drug against the instructions ( called. off-label ). It turns out that last year only a matter of explaining the controversy associated with the use of Avastin in the treatment of AMD gained momentum.
In February 2014 years the Italian Competition Authority fined Roche and Novartis penalty of more than 180 million euros for actions kartelizacyjne associated with two major ophthalmic drugs. In grudniu 2014 years it was announced that the court upheld the charges against the companies.Cartelization is based on the conclusion by the companies in the same industry monopoly agreements aimed at minimizing the mutual competition . It was argued that the company acted in collusion on a drug Avastin (bevacizumab) and orient the demand for more expensive drug called Lucentis (ranibizumab, commercialized in Europe by Novartis) . Avastin is used in accordance with the indications ( ang. off-label use ) by ophthalmologists to treat macular degeneration associated with age ( ang. Age Macular Degeneration-relateg AMD ). Roche is the parent company Genentech (produces both drugs).
Both drugs are monoclonal antibodies that affect the vascular endothelial growth factor ( ang. Vascular Endothelial Growth Factor VEGF ).Bevacizumab ( Avastin ) was first approved in 2004 in the United States as a means of treating colorectal cancer. Shortly after he has attained popularity in the treatment of macular degeneration associated with age ( use not recommended, ang. off-label use ). It was administered by intravitreal injection doses of 400 to 500 times smaller as in the treatment of cancer cases.
Ranibizumab ( Lucentis ) is similar in structure to bevacizumab and was obtained specifically for intravitreal use. Was registered in 2006. In the US and in Europe a year later.
Significant difference in price between Avastin and Lucentis led to the design of comparative tests supported by the US National Institutes of Health and the UK National Health Service Programme . As a result of these activities in six other countries started 7 independent research. These tests showed that the effectiveness of bevacizumab ( Avastin ) and ranibizumab ( Lucentis ) was similar. The study does not have to check for the presence of side effects, which is why they were not able to demonstrate differences in side effects of the two above-mentioned drugs.
The exception was the study carried out in a group where the average age was 79 years. Found a higher number of hospitalizations as a result of administration of Avastin ( ranibizumab ), however, these cases were individuals who were administered the drug as necessary, not in the case of monthly injections.
In the United States it is possible to use bevacizumab (Avastin) as a possible therapeutic option by informing the patient about the treatment was in accordance with the instructions ( ang. off-label status ). WHO ( ang. The World Health Organization ) concluded in April 2013 in The Selection and Use of Essential Medicines possible to use bevacizumab for AMD.
In most European countries the refund process Avastin was difficult for legal reasons. For example, in Italy, to use against the recommendation ( ang. off-label ) was allowed only in the case of medicines in the special list, provided that they have not registered any other pharmacological agent treating a particular disease entity. In June 2014, France Avastin was approved for use in AMD by the French National Assembly .
Information on clinical trials of a similar action of both substances conducted in the United States can be found at clinicaltrials.gov .
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