IQWiG rebuffs Dificlir, Picato

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said on Monday that two drugs offer "no additional benefit" over comparators requested by Germany's Federal Joint Committee (G-BA) because the companies did not provide suitable data. The institute said that Dificlir fidaxomicin from Astellas Pharma Inc. (Tokyo:4503) has "no additional benefit" over comparators to treat Clostridium difficile-associated diarrhea (CDAD). IQWiG said Astellas did not submit data comparing Dificlir with metronidazole, G-BA's requested comparator for mild disease. The institute also said data comparing Dificlir with vancomycin, G-BA's requested comparator for severe or recurrent disease, were "not suitable" because the company only submitted adverse event data for the entire study population, which included patients with mild disease. Astellas has European rights to the macrocyclic narrow-spectrum antibiotic from Optimer Pharmaceuticals Inc. (NASDAQ:OPTR), which was down $0.10 to $14.59 on Monday.

IQWiG also said Picato ingenol mebutate gel from Leo Pharma A/S (Ballerup, Denmark) has "no additional benefit" to treat actinic keratosis because Leo did not submit data directly comparing Picato with hyaluronic acid-containing diclofenac gel, G-BA's requested comparator. IQWiG did not accept data that Leo submitted that indirectly compared Picato with the comparator. ...