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Rhucins MAA -re-evaluatie procedure/tijdspad

1. [verwijderd] 5 januari 2008 15:57

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   MARKETING AUTHORISATION for Rhucin
   
   The Commity for Medicinal Products for Human Use (CHMP) adopted a NEGATIVE opinion by majority on December 13th 2007; review began on August 16th 2006, with an active review time of 176 days.
   
   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.
   
   Pharming may request a re-examination of the opinion within 15 calender days; the applicant shall forward to the Agency the detailed grounds for the request within 60 calender days after receipt of the opinion (so: BEFORE Februari 13th 2008). The re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion. In case the applicant requests that the committee consults a Scientific Advicory Group (SAG) in connection with the re-examination, the applicant should inform the CHMP as soon as possible of this request.
   
   Within 60 calender days following receipt of the grounds for the request, the said Committee shall re-examine its opinion in accordance with the conditions laid down in the fourth subparagraph of Article 62(1). The reasons for the conclusion reached shall be annexed to the final opinion (so: BEFORE April 13th 2008) During the CHMP meeting following receipt of the applicant/MAHs written notice to the Agency that he wishes to request a re-examination of the opinion, the CHMP appoints a different rapporteur and, for opinions where a co-rapporteur was involved in the initial evaluation, a different co-rapporteur from those appointed for the initial opinion (these rapporteurs will coordinate the evaluation for the duration of the re-examination procedure only). At this meeting the CHMP may have preliminary discussions on consultation and composition of the SAG; if possible the CHMP adopts a draft List of Questions to SAG at the same meeting. In case of a request for consultation of the SAG coming from the applicant, the CHMP will systematically consult the SAG. In a therapeutic area where no SAG is established, the advice of additional available expertise will be requested in the form of consultation of an ad hoc expert group meeting. During the CHMP meeting following receipt of the applicant/MAHs written notice to the Agency or detailed grounds for requesting a re-examination of the opinion, the CHMP decides on consultation of the SAG and its composition (with regard to experts other than the SAG core group), and the CHMP adopts a List of Questions to the SAG. If the LOQ to the SAG has not yet been adopted during a CHMP meeting, it will be adopted by written procedure. EMEA will provide to the involved members of the SAG a copy of the List of Questions to the SAG. The CHMP/rapporteurs and the SAG secretary will decide on the additional documents given to the SAG/ad hoc experts, e.g. the applicant/MAH`s detailed grounds, the rapporteur(s)` draft assessment report on the re-examination, the CHMP`s initial opinion. The rapporteur`s assessment report on the re-examination and the (relevant sections of the) LOQ for the SAG is also sent for information to the applicant/MAH. The CHMP will decide whether the applicant/MAH will be invited for an oral presentation to the SAG. The SAG recommendation will be reflected in the CHMP assessment report.The MAH/ applicant in any case has the right to be heard by the CHMP.
   
   Calculation of timetable:
   
   Day 0: receipt by EMEA of Applicant/MAH`s detailed grounds for the request of re-examination.
   
   Day 1: the next calendar day.
   
   Approx. Day 30: Circulation of rapporteur(s)` assessment report(s) to CHMP (including draft LOQ to SAG, if applicable).
   
   Approx. Day 40: CHMP comments.
   
   Approx. Day 45: Joint assessment report (including revised LOQ to SAG if applicable)
   
   Approx. Day 50: if applicable, SAG recommendation to CHMP (through SAG meeting or written procedure)
   
   At the latest on Day 60: The applicant/MAH is given the right to an oral explanation to the CHMP; CHMP adopts opinion (reasons for the conclusion reached shall be annexed to the final opinion). Where the last day of a period is a public holiday/ Saturday/Sunday, the period shall end with the expiry of the last hour of the following working day.