CHMP Positive Opinions: September

CHMP positive opinion of September

New approvals

· Qtrilmet of AstraZeneca

· Rhokiinsa of Aerie Pharmaceuticals

· Xospata of Astellas

Extension of new indication

• Bavencio of Merck

• Benlysta of GSK

• Dupixent of Sanofi

• Lucentis of Novartis

New drugs

Qtrilmet is combination of metformin hydrochloride, saxagliptin and dapagliflozin. The drug is indicated for treatment of type 2 diabetes mellitus in adult patients. The drug combination is 850/1,000 mg metformin hydrochloride, 2.5 mg saxagliptin and 5 mg dapagliflozin.

Rhokiinsa is indicated for the treatment of raising intraocular in patients with primary open-angle glaucoma or ocular hypertension.

Xospata is indicated for the treatment of relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. The drug is indicated for the treatment of adult patients.

Extension of indication

Bavencio (avelumab)

The drug is indicated in combination with axitinib for renal cell carcinoma. The approval was based on Phase III JAVELIN Renal 101 study. The drug demonstrated significant improvement in the progression free survival (PFS) and objective response rate (ORR).

Benlysta (belimumab)

CHMP has given positive opinion for the indication of Benlysta (belimumab) for the treatment of lupus in children of age 5 years and above.

The approval is based on the PLUTO study. Improvement in SLE responder index (SRI) response rate was high (52.8%) in patients administered with Benlysta compared to placebo (43.6%).

The product was found to be safe with no major side effects.

Earlier FDA has approved the same for the same indication.

Dupixent (dupilumab)

CHMP has given positive opinion for adults with severe chronic rhinosinusitis with nasal polyposis. It was approved based on two studies: 24-week SINUS-24 and 52-week SINUS-52.

Lucentis (ranibizumab)

CHMP gave positive opinion for Novartis’ Lucentis for the treatment of proliferative diabetic retinopathy in adults.