Committee for Medicinal Products for Human Use Archives

Janssen gets positive CHMP opinion for Imbruvica for adults with untreated chronic lymphocytic leukemia

Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL).

In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic lymphocytic leukemia and Waldenström’s macroglobulinemia, also known as lymphoplasmacytic lymphoma.

CHMP’s recent positive opinion was based on the Phase 3 GLOW and Phase 2 CAPTIVATE studies.

Janssen noted in a press release that if the new indication is approved, Imbruvica will be the first oral, once-daily, fixed-duration, combination regimen for first-line treatment of CLL.

Janssen developed the drug with Pharmacyclics LLC, an AbbVie company.

Imbruvica is a Bruton’s tyrosine kinase inhibitor. Venetoclax is an apoptosis stimulant and proto…

Valneva anticipates EMA nod for its COVID-19 vaccine candidate in April

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate.

The firm announced on February 25 that CHMP had sent the company a series of questions as part of its initial assessment, to which it responded within two working days.

It anticipates that it can swiftly respond to the latest batch of questions.

Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022.

In such a case, the company would supply European countries with the vaccine in the second quarter of the year.

Valneva has an agreement with the European Commission to provide up to 60 million doses of the vaccine over two years.

The company says t…

EU committee backs Pfizer-BioNTech vaccine booster doses

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ: BNTX) have received a positive opinion from the E.U.’s Committee for Medicinal Products for Human Use (CHMP) for the use of a Comirnaty booster dose in individuals at least 18 years of age at least six months after the second dose.

The European Commission (EC) will likely make a formal decision on the matter soon. Backing from EC will clear the way for Pfizer-BioNTech boosters throughout the E.U.’s 27 member nations.

BioNTech and Pfizer have provided data to European authorities regarding the safety and efficacy of a booster dose of Comirnaty, also known as BNT162b2.

In September, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) considered expanding the approval of the Comirnaty vaccine to include a booster dose with similar criteria. That committee, however, recommended narrowing the scope of boosters to patients facing a higher than average risk of exposure or severe outcomes from C…