G-BA assesses Dificlir, Zytiga and Picato
Germany's Federal Joint Committee (G-BA) issued final benefit assessments for three drugs on Thursday. G-BA said Dificlir fidaxomicin from Astellas Pharma Inc. (Tokyo:4503) has "significant" additional benefit over vancomycin to treat severe or recurrent Clostridium difficile-associated diarrhea (CDAD). In an April preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Dificlir had "no additional benefit" because Astellas did not provide suitable data; G-BA said it considered additional data submitted by the pharma during the comment period. G-BA agreed with IQWiG that Dificlir has "no additional benefit" over metronidazole, G-BA's requested comparator for mild CDAD, because Astellas did not submit data. The pharma has European rights to the macrocyclic narrow-spectrum antibiotic from Optimer Pharmaceuticals Inc. (NASDAQ:OPTR), which was up $0.41 to $15.59 on Friday.
Additionally, G-BA said Zytiga abiraterone from Johnson & Johnson (NYSE:JNJ) has "significant" additional benefit over "watchful waiting" to treat chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CPRC) -- a newly approved indication. The assessment is line with IQWiG's April assessment. ...