Regulatory Affairs- Advisory committee

Published: 2019-11-28 08:30:00
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1. Not evidenced means that there was no sufficient data on the effectiveness for pimavanserin for the treatment of psychosis. The data collected was perceived not enough in helping the committee members to give an ultimate conclusion on the matter. For example, there was only one successful trial that was done on severe patients, the size of the data was relatively low and hence the not evidenced according to the committee. Not evidenced would interpret that more data is needed before approval was made.

2. The primary voting questions were three. The first one tries to find if the applicant provided substantial evidence of the effectiveness of pimavanserin for the purpose of treating psychosis that is associated with Parkinson's disorder. On the second question, the committee examined if the applicant had provided adequate characterization of the safety profile for the pimavanserin. The last issue evaluated if the benefits of using pimavanserin in the treatment of Parkinson's disorder were more than the risks involved. In the first question, the votes were 12, yes, and two no. There was not one who abstained their vote or failed to vote. Those who voted yes had different reasons for their voting with the most common being, there was a reasonable degree of certainty that pimavanserin was beneficial, but there was little evidence it had some risks. Secondly, those who voted yes pointed that though the data size was a point of concern, there was some consistency in the outcome. They also cite there was nothing to compare it with and even with little evidence they would have voted yes. Those who voted no were not convinced by the data provided. In the second question, those who voted yes were 11 and three no. No one abstained their vote or did not vote. Those who voted yes were convinced by the data provided by the applicant. Those who voted no were concerned with the available data would prevent them from giving a conclusion. In question 3, the voting was yes 12 and two no. Those who voted yes argued that the benefits shown by the research outweighed the risks of the drug, while those voted no argued that there concerned that patients need a sure safety in treatment.

3. On the evaluation of the risks and the benefits, pimavanserin was found to add valued to the life of patients since there was no alternative and even if the data collected was not enough. Patients who had suffered for some time had shown improvement after using the drug.

4. The Advisory Committee was supposed to discuss additional trial made by the applicant on the new drug, Northera, droxidopa capsules made for treatment of neurogenic orthostatic hypotension in patients who are found to have an autonomic failure. The Advisory Committee was to vote on if the members would if they wanted the drug in the market or not. The votes were 16 yes and one no. Those who voted yes had different reasons such as the drug had a positive effect on patients health. Also, it was observed that the company had followed the direction FDA and have taken moves of taking the study forward. It was also pointed out that orthostatic hypotension was a terrible disease and since there was some improvement in some patients, and given there was no alternative it was convincing to let it stay in the market. The no vote was because of lack of durable data and poor quality of the trial.

sheldon

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