Re: Farmas USA
CEMP
Y la última página (32-33) es brutal:
There are two avenuesto consider regarding regulatory action when taking into account the uncertainties and significant gaps in current clinical study data that prevent an accurate prediction of the level of risk that solithromycin treatment has for clinically serious idiosyncratic DILI in alarge post-market
exposure population with CABP or other conditions. Which of these
avenues should be followed depends on whether the benefits of solithromycin
treatment have convincingly been shown to have 1) a substantial advantage in
effectiveness for a segment of CABP patients over existing approved treatments, 2) a therapeutic role in the treatment of CABP by organisms that are resistant to other macrolides, and 3) a demonstrated safety advantage for non-liver serious AEs. In the absence of any of these, to strengthen confidence that the risk for serious DILI with this ketolide is well below ~1/330 (as can be determined fromcurrent data), and to elevate the statistical
power for evaluating DILI risk of these events in CABP patients, the number of
study subjects treated with solithromycin should be increased from 924 to approximately 12,000 and carefully assessed for liver safety events, either in
expanded Phase III randomized trials or in a large clinical safety study,
in advance of making a regulatory decision regarding approval for CABP.
EDITO: Me suena que alguno la llevabais. Lo siento. Yo me he abstenido de meterle corto a 16 mientras me informaba y ya va por los 13 :(