• ipharmaservices

JULY 2020 CHMP POSITIVE OPINION

ADAKVEO (crizanlizumab)

Adakveo received a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) for preventing the recurrent vaso-occlusive crises (VOCs) in patients with sickle cell disease. The product is available as a solution for infusion. The drug can be administered as monotherapy or in combination with hydroxyurea/hydroxycarbamide (HU/HC).

The drug has received orphan designation.

Novartis is the market authorization holder of Adakveo.




ARIKAYCE LIPOSOMAL (amikacin)

Arikayce liposomal (amikacin) received a positive recommendation for treating non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults. The drug is intended to treat patients who are not infected with cystic fibrosis.

The drug is intended as a nebulizer.

Also read: UNITED STATES HEALTHCARE SYSTEM


AYVAKYT (avapritinib)

Blueprint Medicines’ Ayvakyt has been approved for unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. The drug is available as an oral dosage form; the drug inhibits oncogenic KIT and PDGFRA mutants.

The drug has received orphan designation.


Also read: CANADA HEALTHCARE SYSTEM

BLENREP (belantamab mafodotin)

Blenrep received CHMP positive opinion for relapsed and refractory multiple myeloma. Belantamab is a humanized IgG1κ monoclonal antibody. The antibody-drug conjugate binds to BCMA on myeloma cell, causing the arrest of cell-cycle. GSK has developed Blenrep.

The product has received orphan designation.

CALQUENCE (acalabrutinib)

AstraZeneca’s Calquene has received the CHMP positive opinion for treating chronic lymphocytic leukemia. The drug is administered as hard capsules. The drug is a protein kinase inhibitor, acts by inhibiting the Bruton tyrosine kinase (BTK). The drug has been able to improve progression-free survival.

The product has received orphan designation.


JYSELECA (filgotinib)

Jyseleca has received CHMP positive opinion for treating rheumatoid arthritis. Gilead has the market authorization of the drug. The drug acts by inhibiting the Janus kinase (JAK) family. The drug has indicated in the form of fim-coated tablets.

Also read: HEALTHCARE SYSTEM OF ITALY


ZYNRELEF (bupivacaine/meloxicam)

Zynrelef has been approved for post-operative pain. Heron Therapeutics has received the CHMP positive opinion for Xynrelef.

EXTENSION OF INDICATIONS

IMFINZI (durvalumab)

Imfinzi, in combination with etoposide and either carboplatin or cisplatin, received CHMP positive opinion for adults with extensive-stage small-cell lung cancer.

AstraZeneca has the market authorization of Imfinzi.


Also read: UNITED STATES HEALTHCARE SYSTEM

Please donate to support iPharmaCenter. Click on donate button in header to support us. Thank you

©2020 by ipharmaservices