Pharmaceutical Technology Editors

The European Medicines Agency announced on Nov. 8, 2021 that it will be reviewing data available on the use of molnupiravir (MK 4482 or Lagevrio) as a treatment for COVID-19 prior to authorization. A rolling review of the drug is currently ongoing. The agency’s Committee for Medicinal Products for Human Use (CHMP) will provide recommendations to national authorities in the European Union regarding the possibly early use of the medication. The decision came because of the rise in infections across the EU.

“EMA and HMA [Heads of Medicines Agencies] remain committed to expediting the evaluation of much needed COVID-19 treatments and vaccines, while ensuring these meet the EU’s high standards of safety and efficacy. EMA will communicate on the outcome of this review and that of the rolling review once they conclude,” the agency stated in a 

Molnupiravir, an oral antiviral medicine that reduces the ability of SARS-CoV-2 to multiply in the body, was developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.

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The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.

EMA Begins Review of COVID-19 Treatment

Pfizer announced on Nov. 5, 2021, that its investigational novel oral antiviral candidate Paxlovid (PF-07321332; ritonavir) significantly reduced severe risks of COVID-19 in a recent clinical trial. According to an interim analysis of the Phase II/III Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, ritonavir demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause within three days of onset relative to the placebo group.

EPIC-HR was a randomized, double-blind study of non-hospitalized patients with COVID-19 considered to be at high risk of progressing to severe illness. Enrolled individuals had a laboratory-confirmed diagnosis of SARS-CoV-2 infection within a five-day period with mild to moderate symptoms. They were required to have at least one characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.

Two groups of patients (randomized 1:1 to receive ritonavir or placebo every 12 hours for five days) were evaluated: those treated within three days of symptom onset, and those treated within five days. In the former group, 0.8% of patients who received ritonavir (3/389) were hospitalized through Day 28; no deaths were reported in this patient group. In that same time frame, 7.0% of patients who received placebo (27/385) were hospitalized; seven deaths were reported in this group.

These values were comparable to those in the five-day group, which reported 1.0% (6/607) and 6.7% (41/612) hospitalization rates, respectively. No deaths were reported in this ritonavir group, while three patients in the placebo group died.

Treatment-emergent adverse events were comparable between ritonavir (19%) and placebo (21%). Among the patients evaluable for treatment-emergent adverse events, fewer serious adverse events (1.7% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.1%) were observed in patients dosed with ritonavir compared to placebo.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” said Albert Bourla, chairman and CEO, Pfizer, in a company press release. “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”

According to the press release, at the recommendation of an independent data monitoring committee and FDA, Pfizer will cease further enrollment in the study. Pfizer plans to submit the data as part of its ongoing rolling submission to FDA for Emergency Use Authorization as soon as possible.

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

Pfizer Pill Reduces Severe COVID-19 Risks by 89% in Phase II/III Study

Element Materials Technology announced on Nov. 4, 2021, that it had signed an agreement to acquire JMI Laboratories, a company specializing in performing antimicrobial resistance surveillance studies.According to a company press release this move was made to strengthen Element’s North American offerings.

JMI uses their proprietary SENTRY Antimicrobial Surveillance Program to perform antimicrobial resistance monitoring studies for FDA regulatory and new drug application submissions. The company also offers microbiology and molecular testing services to assist in development and clinical trial support.

This acquisition is the latest in a series of acquisitions Element has made throughout 2021. Most recently, they purchased a pharmaceuticals contract development and manufacturing organization, 

, in October, and an extractables and leachables specialist, 

“JMI’s SENTRY surveillance program, with over 20 years of data from over 130 hospitals across 40 countries, is a real differentiator,” said Jo Wetz, CEO, Element, in the press release. “Resistance to antibiotics is a clear and present threat to public health on a global scale. With JMI’s team of renowned experts, Element is now positioned to play an important role in helping to address the growing risk of antimicrobial resistance.”

“After 20 years of operation and having built a strong reputation for our expertise and client relationships, we are proud to be joining the Element group,” said Andrew Fuhrmeister, CEO, JMI, in the press release.“This move will bring us wider global access through the Element network and will allow us to work within the expanded life sciences offering, building industry leadership.”

Element’s acquisition of JMI Laboratories will increase their North American service offerings.

Element Acquires JMI Laboratories

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on Nov. 4, 2021 that it has determined that the antiviral drug Lagevrio (molnupiravir) is safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections. MHRA made the determination after a review of the drug’s safety, quality, and effectiveness by the UK’s Commission on Human Medicines.

Lagevrio, developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), interferes with replication of SARS-CoV-2, according to MHRA, which keeps virus levels low in the body. It is most effective when taken early in the infection stages. It has been authorized for use in those with mild to moderate COVID-19 who also have at least one risk factor.

“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage. With no compromises on quality, safety, and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data,” said Dr June Raine, MHRA chief executive, in a

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

MHRA Approves COVID-19 Antiviral Drug

The European Medicines Agency announced on Nov. 2, 2021 that it was stopping its rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV decided to remove the treatments from the review process. EMA’s Committee for Medicinal Products for Human Use (CHMP) had been reviewing data on the two products as part of the rolling review since March 2021. According to EMA, there were questions about the quality of the treatments.

, the company stated that “CHMP has determined that prospective concurrent validation is required for submission of a formal marketing authorisation application. Given the current demand from EU member states, Lilly forecasts that no additional/new drug substance manufacturing campaigns will be needed for the foreseeable future. Therefore, at this point Lilly is not in a position to generate the additional data required by the CHMP to progress to a formal marketing authorization application.”

EMA stated in a press release that Lilly may request another rolling review or submit an application for market authorization in the future. “The withdrawal has no consequences on the previous advice issued in March and patients may continue to receive the medicines based on national arrangements,” the agency stated in the release.

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

Eli Lilly Withdraws COVID-19 Treatments from EMA Review

Waters and Sartorius announced on Oct. 27, 2021, that they would partner to provide bioprocess experts with direct access to mass spectrometry (MS) data to accelerate the speed and improve the accuracy of biopharmaceutical process development. The two companies will implement Waters’ BioAccord Liquid Chromatography (LC)–MS System as a new bioprocess analyzer for Sartorius' Ambr multi-parallel bioreactor systems.

According to the press release, when combined with Waters’ LC–MS system, the speed and accuracy of Sartorius’ bioreactor will be significantly increased in tasks such as clone selection and bioprocess optimization. The companies hope to use this combination to decrease tasks that can take over a month to two days or less while providing more control to bioprocess scientists in obtaining MS data for drug substance and cell culture media samples.

“Waters and Sartorius share a commitment to biopharmaceutical customers to solve their problems with the very best process and analytical tools,” said Davy Petit, senior director of Global Pharmaceutical and Biomedical Research Business, Waters, in the press release. “Clone selection and process development can benefit significantly from at-line versatile mass spectrometry data, which can help bioprocess engineers accelerate workflows and increase confidence in making critical decisions. The combination of our technology in the hands of bioprocess scientists, alongside the well-established Sartorius Ambr bioreactor systems installed-base, can significantly reduce the development timeline for delivery of medicines and vaccines.”

“The combination of Ambr and the easy-to-use at-line Waters BioAccord LC–MS System will save bioprocess scientists substantial time and accelerate clone selection and upstream process development,” said Mario Becker, head of Product Management Cell Culture Technologies at Sartorius, in the press release. “The closer we can bring fundamentally important MS data to the point where it is needed, and the more Ambr samples that can be tested for quality attributes, the better we can provide bioprocess scientists a more complete picture of drug product quality at any point during cell-line, media, and process development. Eventually, we can envisage such process control, monitoring, and product quality testing being fully integrated into the manufacturing environment.”

The partnership between Waters and Sartorius aims to accelerate speed and increase accuracy in bioprocessing analysis.