Earlier this year Arena Pharmaceuticals were disappointed to hear that they wouldn’t get an FDA approval even though they met their trial goals and achieved statistically significant results on all three primary endpoints (se last post on significance).The BLOSSOM trial showed an average weight loss of 5.8% (2.2 in placebo group), and 22.6% lost more than 10% of their bodyweight. FDA requires that at least 35% should lose 5% or more weight- and this was achieved, but the difference between the placebo group and the lorcaserin patient group did not make it to the 5% mark. In the meantime the shares for Arena Pharmaceuticals dropped 20%.
On December 22nd Arena Pharmaceuticals announced that they are applying for FDA approval again, backed up by the results from the second year-long trial with 4,000 patients. But the second study still does not meet all the criteria’s set by the FDA. Arena claims this drug is safe ( in 1997 Wyeth had to recall a drug due to heart valve problems)- and should get an FDA approval.