Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

USA

FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer

The Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

FDA Approves New Treatment for Hemophilia A or B

The U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies).

FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities

The U.S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that causes flu).

FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

The Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

EUROPE

Translarna: EMA re-confirms non-renewal of authorisation of Duchenne muscular dystrophy medicine

Translarna is used for treating patients with Duchenne muscular dystrophy aged 2 years and older who are able to walk and whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene.

AUSTRALIA

TGA’s decision to not register lecanemab (LEQEMBI)

The Therapeutic Goods Administration (TGA) has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and Mild Alzheimer’s dementia (early Alzheimer’s disease).

Nitrosamine impurities acceptable intakes update – October 2024

It has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information- external site. The changes include additional clarification for sponsors and manufacturers of the TGA’s expectations, minor editorial amendments, increases to the AI limit for some nitrosamine impurities and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.

CANADA

Acrobat-i Stabilizer Z and Acrobat-i Positioner Z

The contract manufacturer of the Acrobat product family reported deviations in the manufacturing process that creates the sterile barrier. Specifically, in some instances, the tray sealing step was performed multiple times using the same package, which is outside of the validated process. Although testing suggests that product is sterile immediately after being sealed with this non-validated process, we cannot ensure that the product will remain sterile for the duration of its 2-year shelf life.

Ak98 Hemodialysis Machine

Baxter Healthcare Corporation (Baxter) is in the process of implementing an urgent medical device correction for the Ak98 hemodialysis machines listed. These devices are manufactured using peroxide-cured silicone tubing within the hydraulic circuit. The Baxter Ak98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload.

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and ndl polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing.

Adult Nasal Cannula

CHS Ltd. has received customer feedback indicating they had experienced partial blockage of the adult nasal cannula prongs which was impeding the flow of oxygen to the patient. As a result of this situation, CHS conducted an investigation and has been able to confirm this defect. Therefore, CHS is issuing this recall to address these concerns. While there has been no reports of patient injuries to date, CHS has identified this as a type II recall.

JAPAN

PMDA Risk Communications (drug risk information of ongoing evaluation)

Risk information suggested by a certain amount of accumulated information of adverse drug reactions (ADR) reports or Early Post-marketing Phase Vigilance (EPPV)

Safety measures such as revision of PRECAUTIONS in the package insert of the product might be taken after the ongoing review.

SINGAPORE

Gavreto® (pralsetinib) – new warning and precaution of severe and fatal infections

A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals that severe and fatal infections, including opportunistic infections, have been reported in patients treated with Gavreto®. An ad hoc analysis of results from the ongoing phase III trial AcceleRET-Lung demonstrated an imbalance regarding the risk of severe and fatal infection, including severe opportunistic infections, between the pralsetinib and standard of care arms. Healthcare professionals are advised to monitor patients closely for signs and symptoms of infection and treat appropriately. They are also advised to withhold Gavreto® in the presence of active infection and discontinue Gavreto® permanently if infections are life-threatening.

Q-Nic Care Whitening Underarm Cream” Detected To Contain Very High Levels Of Mercury And A Potent Steroid

The Health Sciences Authority (HSA) is alerting members of the public not to purchase or use “Q-nic Care Whitening Underarm Cream”. The cream was touted to help reduce body odour, whiten and smoothen skin tone and claimed to be “safe, natural, non-toxic and harmless to your skin”. However, HSA’s test revealed that the cream contained potent ingredients, including very high levels of mercury, a potent steroid (betamethasone valerate) and a preservative (triclosan) that is not allowed in cosmetic skin creams.

Recall of Apo-Amitriptyline 10mg & 25mg Tablets

Retail-level recall of eight batches of Apo-Amitriptyline 10mg Tablet and three batches of Apo-Amitriptyline 25mg Tablet, containing amitriptyline, due to detection of an impurity above the acceptable level.

When evaluations are completed, the information in the table below will be deleted.

UK

Sugemalimab approved to treat adult patients with non-small cell lung cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (Eqjubi) to treat adult patients with a type of lung cancer called ‘non-small cell lung cancer’. 

MHRA reminds healthcare professionals to advise patients of the side effects of GLP-1 agonists and to report misuse

The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding healthcare professionals to ensure patients are aware of the known side effects of glucagon-like peptide-1 (GLP-1) receptor agonists.
These medicines are used to treat type 2 diabetes or obesity, with the common risk of gastrointestinal side effects which may affect more than 1 in 10 patients. While most side effects for these medicines are mild, some may also be serious.

Donanemab licensed for early stages of Alzheimer’s disease in adult patients who have one or no copies of apolipoprotein E4 gene

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a licence for the medicine donanemab (Kisunla) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
Donanemab works by removing a sticky protein called beta-amyloid from the brain that is believed to cause Alzheimer’s disease, and in the trials conducted the medicine showed some evidence of efficacy in slowing its progression.