European Medicines Agency Archives - Medical Design Sourcing

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…

Oncopeptides’ Pepaxti wins positive opinion from CHMP for multiple myeloma patients

Oncopeptides AB (Nasdaq Stockholm:ONCO) has won a unanimous positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Pepaxti (melphalan flufenamide) in the EU.

The European Commission will make a final decision on the drug candidate in the next 60 days.

An approval would make the drug available throughout the EU and in Iceland, Liechtenstein and Norway.

Stockholm-based Oncopeptides received FDA approval for the drug, marketed as Pepaxto, combined with dexamethasone for some adult patients with relapsed or refractory multiple myeloma on February 26, 2021.

Oncopeptides voluntarily withdrew the drug after the Phase 3 study on October 22, 2021, after analyzing data from the Phase 3 OCEAN study.

In March 2022, Oncopeptides rescinded its prior letter asking for voluntary withdrawal of melphalan flufenamide in the U.S. In a press release, the company explained that further data rev…

Valneva aims to salvage COVID-19 vaccine deal with EU

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) is hoping to change the European Commission’s (EC) mind after regulators notified the firm that they intend to terminate an Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine candidate VLA2001.

VALN shares fell 15% to $20.00.

In February, Valneva announced that it expected authorization for the vaccine in the European Union in April. Regulators from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had sent the company several questions about the vaccine candidate. Valneva said then that it swiftly answered them.

EMA accepted the filing of the Marketing Authorization Application on May 19.

After the European Commission received Valneva’s remediation plan, Valneva hopes to have further discussions with regulators interested in its inactivated, adjuvanted whole-virus vaccine.

Valneva ind…

Biogen gives up seeking European approval for aducanumab

After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks.

Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021.

At that time, Biogen announced that it would fight the decision.

In April, the company notified EMA that its decision to withdraw its application was “based on interactions with the CHMP [Committee for Medicinal Products for Human Use] indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm (aducanumab).”

“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” said Dr. Priya Singhal, head of global safety and regulatory sciences …

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…

Moderna pursues EU authorization of its COVID-19 vaccine in children aged 6 to 11

Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union.

Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union.

Last week, the company announced that FDA had delayed its review of the mRNA-1273 vaccine in 12- to 17-year-olds to investigate reports of myocarditis apparently linked to the vaccine.

EU regulatory authorities have not yet authorized a COVID-19 vaccine for children younger than 12. The Austrian capital of Vienna, however, will begin vaccinating young children against the novel coronavirus on November 12.

Cambridge, Massachusetts–based Moderna has an ongoing Phase 2 trial, dubbed “KidCOVE,” investigating the use of its vaccine in children as young as 6 months of age.

The company reports that vaccine efficacy — measured as protection against sympt…

EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

Image courtesy of Wikipedia

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature.

Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.

Get the full story at our sister site, Pharmaceutical Processing World.

EU OKs Moderna COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of European Medicines Agency (EMA), in a statement. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

EMA has also authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) on Dec. 21. It has not, however, given the greenlight to the vaccine from Oxford University and AstraZeneca, which is now available in the U.…