After CRL in 2022, Pfizer and OPKO get FDA nod for pediatric growth hormone deficiency med

Pfiz­er and OP­KO Health have fi­nal­ly cleared the reg­u­la­to­ry hur­dle at FDA for their once-week­ly, long-act­ing growth hor­mone de­fi­cien­cy drug Ngen­la, though As­cendis Phar­ma beat them with the ap­proval of Skytro­fa in Au­gust 2021.

The agency gave Ngen­la a thumbs down in Jan­u­ary of last year, with no rea­son cit­ed by Pfiz­er. The duo, part­ners since 2014, had got­ten the go-ahead in more than 40 oth­er mar­kets al­ready.

To read Endpoints News become a free subscriber

Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters

SIGN UP LOG IN