Pharmaceutical Business review

Forest Laboratories Teflaro gets FDA nod

The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI).

In the CABP trials, 1,231 adult patients received Teflaro or Rocephin, and the clinical response was based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint.

Where as, in ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam, where the clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint.

In both trials, the effectiveness of Teflaro was comparable to Rocephin.