Pharmaceutical Technology Editors

Pfizer has issued a voluntary recall of Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/hydrochlorothiazide) on a consumer level due to the presence of a nitrosamine, N-nitroso-quinapril, that is above the Acceptable Daily Intake (ADI) level. The recall includes six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets.

The tablets are used for the treatment of hypertension, focused on lowering blood pressure to reduce the risk of cardiovascular issues. There have been no reports to Pfizer of any adverse effects that have resulted from the products in this recall. Pfizer has stated that there is no immediate risk to patients taking the medication in a press release.

Nitrosamines are common in things people come in contact with every day, such as water and certain foods like grilled meats and dairy products. Everyone is exposed to some level of nitrosamines, though long-term exposure of them that exceed the ADI level may increase the risk of cancer, according to the company.

The product lots were distributed nationwide to distributers and wholesalers in the United States and Puerto Rico from November 2019 to March 2022. Pfizer has issued letters to entities in possession of these lots for the return of the recalled product.

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Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.

Pfizer Issues Voluntary Recall of Blood Pressure Tablets Due to High Levels of Nitrosamine

Novavax, a vaccine development and commercialization company, and Serum Institute of India, the world’s largest vaccine manufacturer by volume, announced on March 22, 2022 that Novavax’ COVID-19 vaccine has been granted emergency use authorization (EUA) for adolescents aged 12–18 by the Drugs Controller General of India (DCGI). The protein-based vaccine is currently manufactured in India and marketed under the brand name Covovax.

The EUA for Covovax was initially granted for adults aged 18 years and over in India in December 2021. It is the first protein-based vaccine authorized for the age group of 12–18 in India.

"We're proud of this first approval in adolescents given the efficacy and safety that our data show in this population, and that our COVID-19 vaccine will provide an alternative protein-based vaccine option for individuals 12 years of age and older in India," said Stanley C. Erck, president and CEO of Novavax, in a press release. "We hope that this authorization of our COVID-19 vaccine in adolescents is the first of many worldwide so that families have an additional choice built on a well-understood platform used in other vaccines for decades."

"The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, CEO of Serum Institute of India, in a press release. "We are proud to deliver a protein-based COVID-19 vaccine with a favorable safety profile to the adolescents of our nation."

Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.

Novavax and Serum Institute of India Announce Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents Ages 12 to 18 in India

Novartis announced on March 23, 2022 that FDA has approved its targeted radioligand therapy Pluvicto for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC). These patients have already gone through androgen receptor pathway inhibition and taxane-based chemotherapy treatments.

Pluvicto combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle), providing another treatment option for patients with progressing mCRPC. The treatment is expected to be available to physicians and patients within weeks.

“The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” said Oliver Sartor, M.D., medical director at Tulane Cancer Center. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”

“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients,” said Jamie Bearse, CEO and president at ZERO – The End of Prostate Cancer. “The approval of Pluvicto offers new hope to the mCRPC community.”

FDA has approved Novartis’ targeted radioligand therapy Pluvicto for the treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer.

Novartis’ Pluvicto Approved by FDA for Treatment of Advanced Prostate Cancer

Orion, a Finnish pharmaceutical company, is planning to change and refocus its R&D function to focus on cancer and pain. The company plans to invest in the research and development of new proprietary drugs focused on treatments for patients’ needs regarding cancer and pain. The R&D refocus is expected to be completed by the summer of 2022.

Orion will no longer invest in various areas of research that it had previously focused on, including neurodegenerative diseases and rare diseases. Orion has been conducting R&D for cancer treatments and pain management for years, but the shift in focus will make these areas of research the company’s main priority.

The planned R&D of new proprietary products for cancer and pain would not have an effect on the company’s current portfolio of products, including inhaled pulmonary drugs and existing neurological disease products.

“Research in cancer diseases and pain management are very active fields where a lot of good results are being produced. There is still much to be achieved in these fields from the point of view of patients,” said Outi Vaarala, Orion’s senior vice president of R&D, in a press release. “With the planned changes, we want to concentrate investment in research and development on proprietary drugs in these therapy areas. Oncology is already well represented in our development projects. We have promising new research projects for pain management, and we expect to proceed to clinical trials within the next 12 months. We have also worked hard to identify new opportunities for cooperation in pain management. The idea is to focus investment in these areas and to develop treatments for patients as efficiently as possible, rather than making smaller investments in a larger number of research areas. This is also the most effective way to support Orion’s growth strategy.”

Orion is planning to refocus its R&D efforts on the development of new proprietary products focused on cancer and pain.

Orion to Refocus R&D to Cancer and Pain

Roche announced on March 25, 2022 that the European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). The European Commission (EC) will make a final decision regarding the approval in the near future.

The new Polivy combination’s marketing authorization in the European Union for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for a hematopoietic stem cell transplant will be converted to a full approval once the EC makes a positive final decision.

According to a press release, an estimated 40,000 people in Europe are diagnosed with DLBCL each year, making it the most common form of non-Hodgkin lymphoma. Approximately 40% of people with previously untreated DLBCL are not cured with the current standard of care and face a poor prognosis.

“A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an aggressive form of blood cancer, do not respond adequately to existing therapies,” said Levi Garraway, Roche’s chief marketing officer and head of global product development, in a press release. “Therefore, more treatment options are needed that could increase a person's chance of cure, and we look forward to bringing this new Polivy combination to people with DLBCL as soon as possible.”

EMA has recommended the approval of Roche’s Polivy plus R-CHP for the treatment of previously untreated diffuse large B-cell lymphoma in the EU.

EMA Recommends EU Approval of Roche’s Polivy Combination for Diffuse Large B-Cell Lymphoma

The Independent Data Monitoring Committee has recommended that the EMPA-KIDNEY trial evaluating the effect of empagliflozin in adults with chronic kidney disease (CKD) should be stopped early. The Medical Research Council Population Health Research Unit at the University of Oxford, Boehringer Ingelheim, and Eli Lilly announced that this was due to a formal interim assessment that deemed the treatment to be effective based on prespecified criteria.

EMPA-KIDNEY evaluated the efficacy and safety of empagliflozin in certain adults with CKD, including those with mildly to severely reduced eGFR (a measure of kidney function), those with normal and increased levels of albumin (a type of protein present in the urine), those with and without diabetes, and those with CKD attributable to a wide range of underlying diseases.

“As part of the larger community dedicated to helping the millions of people living with chronic kidney disease, the early stop of EMPA-KIDNEY brings us one step closer to achieving this goal much sooner,” said Waheed Jamal, M.D., corporate vice president and head of CardioMetabolic Medicine, Boehringer Ingelheim, in a press release. “EMPA-KIDNEY adds to the success of the EMPOWER trial program which has already demonstrated cardio-renal and metabolic benefits of empagliflozin for millions of people across the globe.”

“EMPA-KIDNEY included a range of adults with kidney disease who have been excluded from, or under-represented in, previous trials focusing on the use of SGLT2 inhibitors to slow kidney disease progression,” said Jeff Emmick, M.D., PhD, vice president, product development, Lilly, in a press release. “The early stop of the trial is a tremendous step toward our goal of improving the lives of adults living with kidney disease.”

Boehringer Ingelheim announced Empagliflozin Phase III EMPA_KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.