Company Product Description Indication Status
Aerie Pharmaceuticals Inc., of Durham, N.C.  Roclanda (latanoprost + netarsudil mesylate) Rho-associated protein kinase inhibitor; PGF2 alpha agonist Glaucoma; ocular hypertension EMA's CHMP recommended approval of MAA for reduction of elevated intraocular pressure in adults with primary open-angle glaucoma or ocular hypertension not helped by monotherapy; EC decision expected early next year
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat  Pyruvate kinase R activator Sickle cell disease (SCD) FDA granted orphan status in SCD
Amgen Inc., of Thousand Oaks, Calif. Kyprolis (carfilzomib) Proteasome inhibitor; ubiquitin inhibitor  Multiple myeloma (MM) EMA's CHMP recommended update to existing indication supporting Kyprolis treatment with daratumumab and dexamethasone (dex), with lenalidomide and dex, or with dex alone for adults with MM who've received at least one prior therapy
Bayer AG, of Leverkusen, Germany Xarelto (rivaroxaban) Factor Xa antagonist Venous thromboembolism EMA's CHMP recommended new strength and new indication: treatment of VTE and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment
Biomarin Pharmaceutical Inc., of San Rafael, Calif. Roctavian (valoctocogene roxaparvovec) F8 gene stimulator Factor VIII deficiency Subsidiary Biomarin International Ltd. withdrew MAA for treatment of severe hemophilia A; received FDA CRL in August
Boehringer Ingelheim International GmbH, of Ingelheim, Germany Pradaxa (dabigatran etexilate) Factor IIa antagonist; protease-activated receptor-1 antagonist Venous thromboembolism EMA's CHMP recommended new form and strength together with new indication for treatment of VTE and prevention of recurrent VTE in pediatric patients from birth to less than 18 years of age
Chiesi Farmaceutici SpA, of Parma, Italy Trimbow (beclometasone / formoterol / glycopyrronium bromide) Beta 2 adrenoceptor agonist; muscarinic receptor antagonist; glucocorticoid receptor agonist Asthma EMA's CHMP recommended new strength and new indication: maintenance treatment of asthma
Heron Therapeutics Inc., of San Diego HTX-011 (bupivacaine + meloxicam) Cyclooxygenase 2 inhibitor; sodium channel inhibitor Pain Resubmitted NDA following June CRL; class 2 resubmission
Innate Pharma SA, of Paris Lacutamab Anti-KIR3DL2 humanized cytotoxicity-inducing antibody Sézary syndrome EMA granted PRIME designation for 3L treatment of relapsed or refractory Sézary syndrome patients
Menari Group, of Florence, Italy Elzonris (tagraxofusp) IL-3 receptor modulator; CDw123 modulator Blastic plasmacytoid dendritic cell neoplasm (BPDCN) Following re-examination, EMA's CHMP recommended approval for a restricted indication in patients who had not yet received any treatment for BPDCN
Moderna Inc., of Cambridge, Mass. mRNA-1273 COVID-19 Spike glycoprotein modulator COVID-19 infection Swissmedic started a rolling review
Roche Holding AG, of Basel, Switzerland Phesgo (pertuzumab + trastuzumab) Erbb2 tyrosine kinase receptor inhibitor  Metastatic breast cancer (MAA); breast tumor EMA's CHMP recommended approval of MAA
Roche Holding AG, of Basel, Switzerland and Shionogi & Co. Ltd., of Osaka, Japan Xofluza (baloxavir marboxil) Endonuclease inhibitor Influenza virus infection EMA's CHMP recommended approval of MAA for the treatment of uncomplicated influenza in patients aged 12 years and above
Samsung Bioepis Co. Ltd., of Incheon, Korea Onbevzi (bevacizumab) Anti-VEGF antibody Multiple cancers EMA's CHMP recommended approval of MAA
Swedish Orphan Biovitrum AB, of Stockholm Gamifant (emapalumab) Interferon gamma ligand inhibitor Hemophagocytic lymphohistiocytosis EMA's CHMP re-examined initial negative opinion, confirmed its refusal to recommend granting MAA
UCB SA, of Brussels, Belgium Xyrem (sodium oxybate) GABA B receptor agonist Narcolepsy; cataplexy EMA's CHMP recommended extending indication to include treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years
Viiv Healthcare Ltd., of London Tivicay (dolutegravir) HIV-1 integrase inhibitor HIV-1 infection EMA's CHMP recommended new form and strength together with new indication: combination with other anti-retroviral medicinal products for the treatment of HIV-infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg


For more information about individual companies and/or products, see Cortellis.