FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

CHMP Recommends Seven Drugs for Approval

Jan. 7, 2019
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The EMA’s Committee for Medicinal Products for Human Use recommended seven medicines for approval by the European Commission.

The CHMP issued positive opinions for two orphan drugs, PharmaEssentia’s Besremi (ropeginterferon alfa-2b), for the treatment of abnormal levels of hemoglobin, and Medac’s Trecondi (treosulfan), for conditioning treatment prior to stem cell transplantation.

The CHMP also recommended Shionogi's Mulpleta (lusutrombopag) for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures, as well as the manufacturer’s Rizmoic (naldemedine), indicated for opioid-induced constipation.

The committee recommended Pfizer’s hybrid medicine Tobramycin PARI (tobramycin), for management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients six years and older. It also issued a positive opinion for Zirabev (bevacizumab), Pfizer’s biosimilar for Genentech’s oncology drug Avastin.

Lastly, the committee issued a positive opinion for Diapharma’s Miglustat Dipharma (miglustat), a generic version of Actelion’s Zavesca for treatment of adult patients with mild to moderate type 1 Gaucher disease.

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