Drug Filing

Novartis plans to file for new Lucentis indication in ROP

Novartis has unveiled plans to file ex-US for a new indication for Lucentis (ranibizumab) in retinopathy of prematurity (ROP), a rare disease in premature infants.

OBI Pharma’s OBI-3424 gets FDA orphan drug status to treat ALL

OBI Pharma’s small-molecule prodrug OBI-3424 has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute lymphoblastic leukemia (ALL).

Ironwood secures FDA fast track designation for heart drug praliciguat

Ironwood Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer

The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.

Alexion seeks approval from FDA for PNH drug ALXN1210

Alexion Pharmaceuticals said that it has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA), seeking approval for its C5 complement inhibitor ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).

AbbVie seeks US approval for psoriasis drug risankizumab

AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration seeking approval of risankizumab for the treatment of moderate to severe plaque psoriasis.

Sarepta plans to submit NDA for Golodirsen Duchenne drug by year end

Sarepta Therapeutics has is planning to submit a new drug application (NDA) for accelerated approval of its duchenne muscular dystrophy (DMD) drug Golodirsen (SRP-4053).

Alnylam, Sanofi submit MAA to EMA for patisiran to treat hereditary ATTR amyloidosis

Alnylam Pharmaceuticals and Sanofi Genzyme have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

Pharming submits supplemental BLA to FDA for Ruconest for prophylaxis of hereditary angioedema attacks

Pharming Group has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).