stevenl schreef:
nogmaals de letterlijke text:
What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
The CHMP was concerned that there was insufficient evidence to show the benefits and risks of Rhucin.
In particular, the available studies were too small to show how effective Rhucin is in treating more severe forms of the disease, such as swelling in the larynx (voice box), or how safe and effective the medicine is when given to a patient more than once.
There was also insufficient information over the likelihood of patients developing antibodies following repeated doses of Rhucin. The Committee was also concerned over the possible presence of impurities in Rhucin, which could come from the rabbit milk from which the active substance is extracted and could affect the medicine’s safety. The company had not demonstrated that the levels of the impurities or the antibodies could be measured in a reliable manner.
In addition, there were concerns that the choice of the dose of Rhucin had not been sufficiently justified.
At that point in time, the CHMP was of the opinion that the benefits of Rhucin in the treatment of acute attacks of angioedema did not outweigh its risks. Hence, the CHMP recommended that Rhucin be refused marketing authorisation.
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Ze leggen de stress op volgende:
In particular, the available studies were too small to show how effective Rhucin is in treating more severe forms of the disease, such as swelling in the larynx (voice box), or how safe and effective the medicine is when given to a patient more than once.
ben benieuwd hoe Pharming dat gaat oplossen met alleen "papier". Er staat duidelijk te weinig studie.