Pharmaceutical Technology Editors

FDA announced on May 13, 2022 that it has approved Eli Lilly and Company’s Mounjaro (tirzepatide) injections as a once-weekly treatment for adults with type 2 diabetes to help manage blood sugar levels. Tirzepatide is a first-in-class medicine that activates both the glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, which ultimately leads to improved blood sugar control.

The approval follows five clinical trials wherein three different doses of tirzepatide (5 mg, 10 mg, and 15 mg) were evaluated as either a stand-alone therapy or as an add-on to other diabetes medicines. On average, the patients randomized to receive the maximum recommended dose of 15 mg had a lowering of their hemoglobin A1c level by 1.6% more than placebo when used as a stand-alone therapy, and by 1.5% when used as an add-on. Trials comparing it to other medicines found that it lowered levels by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1.0% more than insulin glargine.

Additionally, the study found that participants (largely obese, with an average body mass index measured between 32 and 34 at the time of enrollment) in the tirzepatide groups lost more weight than other treatments. Patients lost 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin. The average weight loss with the maximum recommended dose of tirzepatide was 12 pounds more than semaglutide, 29 pounds more than insulin degludec, and 27 pounds more than insulin glargine. Patients who received insulin without tirzepatide tended to gain weight during the study.

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of [tirzepatide] is an important advance in the treatment of type 2 diabetes,” said Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity, FDA’s Center for Drug Evaluation and Research, in the agency’s press release.

Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether tirzepatide causes such tumors, including medullary thyroid cancer, in humans, but FDA states that it should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2. Reported side effects include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain.

Articles

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

FDA Approves Lilly’s Novel, Dual-Targeted Treatment for Type 2 Diabetes

Pfizer and BioNTech announced on May 17, 2022 that FDA has expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the companies’ COVID-19 vaccine in children five through 11 years of age. The booster dose should be given at least five months after the second dose of the two-dose primary series. More than 8 million children aged 5–11 years old have completed a primary series of the vaccine in the United States to date.

The EUA is based on data that show children five through 11 years of age had a significant immune response following a booster dose of the vaccine during the time when Omicron was the prevalent variant. More than 4000 children in this age range have participated in the companies’ COVID-19 vaccine clinical trial to date.

The companies have also submitted an application to the European Medicines Agency for a booster dose in this age group and plan to file similarly with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 vaccine is currently the only COVID-19 vaccine authorized for use in the US for children in this age group. The vaccine is based on BioNTech’s proprietary mRNA technology, and the company is the Marketing Authorization Holder in the US, European Union, the United Kingdom, and Canada. BioNTech and Pfizer jointly hold EUAs or equivalents in the US and other countries.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children

Pfizer and BioNTech announced on May 13, 2022 that they have reached an agreement with the European Commission (EC) to update their COVID-19 vaccine supply agreement. The update includes rephased planned deliveries to help support the EC and Member States’ immunization programs.

Doses that were scheduled for delivery in June through August 2022 will now be delivered in September through fourth quarter 2022. The delivery schedule change does not affect the companies’ full-year 2022 revenue guidance or the full-year commitment of doses to be delivered to the EC Member States in 2022.

The companies are continuing to evaluate potential variant-based vaccines and expect to share data in the coming months. The Pfizer-BioNTech COVID-19 vaccine is currently authorized under Emergency Use Authorization in individuals five years of age and older.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC

Avacta Group, a clinical-stage oncology drug company, announced that it would be relocating its Therapeutics division on May 11, 2022.The division will now be headquartered at Scale Space in Imperial College’s White City Campus, London, United Kingdom. This move follows Avacta’s recent transition of lead candidate AVA600, a tumor-activated form of doxorubicin, into clinical trials in August 2021.

Scale Space is part of the broader White City Innovation District, which is currently home to over 140 companies across a broad range of industries, including pharmaceutical and biotech. According to a company press release, Avacta’s new HQ will be part of a life science cluster at the west London site.

“This move is the result of a clear vision to bring together the research and development teams into one hub to facilitate the translation of our in-house research from bench to bedside,” said Fiona McLaughlin, chief scientific officer of Avacta, in the press release. “We are now at the heart of the innovative White City community in London, readily accessible to our collaborators around the world and poised to take Avacta to the next level in its evolution as a clinical stage biopharmaceutical company.”

Avacta is relocating its therapeutics headquarters to Scale Space in Imperial College’s White City Campus, London, United Kingdom.

Avacta Establishes New Therapeutics Headquarters

Pfizer announced its $11.7 billion acquisition of Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company, on May 10, 2022. This acquisition will grant Pfizer the rights to rimegepant, a dual-acting migraine therapy approved in the United States for acute treatment and episodic prevention of migraine in adults. It is also approved in the European Union for acute treatment of migraine and prophylaxis of episodic migraine.

According to a company press release, this deal will also grant Pfizer the rights to zavegepant, which is on track for US approval in the second quarter of 2022 as an intranasal spray for the acute treatment of migraine; it is also in development as an oral soft gel for chronic migraine prevention. Additionally, Pfizer will acquire a portfolio of five other preclinical calcitonin gene-related peptide (CGRP) assets.

“Today’s announcement builds on our legacy of delivering breakthroughs for patients living with complex pain disorders and diseases that disproportionately impact women,” said Nick Lagunowich, global president, Pfizer Internal Medicine, in the press release. “[Rimegepant], which is already the [number one] prescribed migraine medicine in its class in the United States, coupled with Biohaven’s CGRP pipeline, offers hope for patients suffering from migraine worldwide.”

“We are excited to announce Pfizer’s proposed acquisition of Biohaven, recognizing the market leadership of [rimegpant], our breakthrough all in one migraine therapy, and the untapped potential of our CGRP franchise,” said Vlad Coric, chairman and CEO, Biohaven, in the press release. “Pfizer’s capabilities will accelerate our mission to deliver our migraine medicines to even more patients, while the new R&D company is well positioned to bring value to patients and shareholders by focusing on our innovative pipeline for neurological and other disorders. We believe this transaction represents significant future value creation for patients and our collective shareholders.”

Pfizer will acquire Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in migraine treatments, for $11.7 billion.

Pfizer to Acquire Biohaven Pharmaceuticals for $11.7 Billion

On May 10, 2022, Avantor announced that it had entered into an agreement with Cytovance Biologics, a contract development and manufacturing organization specializing in plasmid DNA, to manufacture research- and good manufacturing practice (GMP)-grade plasmids for viral vectors and messenger RNA (mRNA)-based vaccines and therapeutics.

Plasmid DNA is a critical process element in viral vector-based gene therapy and mRNA vaccines and therapeutics. Under the agreement, Avantor will provide access to plasmid DNA and other mission-critical inputs used in research, clinical testing, and manufacturing scale-up and commercialization while Cytovance Biologics will lend its plasmid current good manufacturing practice manufacturing capabilities.

"Demand for therapeutic biologics in the gene therapy space is increasing rapidly and will require increased manufacturing capacity and expertise,” said Ger Brophy, executive vice-president, Biopharma Production, Avantor, in a company press release. “Our collaboration with Cytovance Biologics demonstrates our commitment to cell and gene therapy biomanufacturers and will support our role in unlocking the potential these therapies hold for patients around the globe."

“Production of plasmid DNA extends our microbial capabilities to support the growth of the cell and gene therapy space. We are delighted to be working closely with Avantor to support the biopharmaceutical industry on a global level,” said Naomi Seresinhe, senior vice-president of business operations, Cytovance Biologics in the press release.

Through a collaboration, Avantor and Cytovance Biologics will accelerate plasmid optimization and sourcing services for viral vectors and mRNA-based vaccines and therapeutics.