Pharma/Biotech – USA, UK, Asia and ROW Regulatory News – Aug 2024
USA
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).
FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
The U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.
FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
The U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023.
Drug overdose persists as a major public health issue in the U.S., with more than 107,000 reported fatal overdoses occurring in 2023, primarily driven by synthetic opioids like illicit fentanyl. Nalmefene and naloxone are two available options to reverse opioid overdose. The FDA has worked to increase availability and accessibility of both options to encourage harm reduction and reduce overdose death.
FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma
The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices.
AUSTRALIA
New semaglutide product becomes available
Pharmaceutical company Novo Nordisk has advised us that a new brand of semaglutide will be available in Australia from early August 2024.
Wegovy is approved specifically for chronic weight management in adults and adolescents ‘as an adjunct to a reduced-energy diet and increased physical activity when specific criteria are met’. Semaglutide is the same active ingredient found in Ozempic, a type 2 diabetes treatment, which has been subject to intermittent shortages since 2022. See the ‘About the Ozempic (semaglutide) shortages 2022-2024’ webpage for more information.
New quality standards for MDMA and psilocybine
Two new quality standards, one for MDMA and another for psilocybine, have been published. These standards each specify the minimum quality requirements for both the active pharmaceutical ingredient (API) and finished product.
Medicines containing Garcinia gummi-gutta (Garcinia cambogia) or hydroxycitric acid (HCA)
Medicines and herbal supplements containing Garcinia gummi-gutta (Garcinia cambogia) or hydroxycitric acid (HCA) may cause liver injury in rare cases. The risk also relates to other ingredients that contain HCA: Garcinia quaesita, hydroxycitrate complex, calcium hydroxycitrate, sodium hydroxycitrate, or potassium hydroxycitrate.
CANADA
Message from the Minister of Mental Health and Addictions and Associate Minister of Health and the Minister of Health – International Overdose Awareness Day
A day to reflect on the devastating and tragic impact of the toxic drug and overdose crisis and remember our loved ones whose lives have been tragically cut short by overdose. These are our friends, our families, and our neighbours.
This year’s theme, “together we can,” highlights the power we have as a community to come together to prevent overdose deaths by raising awareness around substance use related-harms, reducing stigma, and ensuring people can access the health and social services they need.
CHINA
COVID-19 infections not problematic, experts say
The number of people in China being infected with COVID-19 is fluctuating reasonably and won’t be a burden on medical resources or the public, experts said.
The latest figures from the Chinese Center for Disease Control and Prevention show that fever departments nationwide saw the number of new infections fall from 125,000 on July 1 to 92,000 on July 31. Infections peaked at around 210,000 from February to March.
The number of COVID-19 patients in critical condition last month was 203, the center said, compared with 358 in February and 588 in March.
PHILIPPINES
Training on the Pharmaceutical Inspection Cooperation Scheme-Good Manufacturing Practice Guide PE 009-14: Current Regulatory Requirements (PIC/S-GMPCRR)
This training will provide discussion of the provisions stipulated in the current version (ver. 14 of the PIC/S-GMP Guide) and other regulatory requirements to comply with Good Manufacturing Practice for Pharmaceuticals
SINGAPORE
Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) is not approved as adjuvant therapy for hepatocellular carcinoma
A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to inform healthcare professionals that Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) is not approved as adjuvant therapy after surgical resection or ablation. Updated analysis data from IMbrave050, a study evaluating atezolizumab in combination with bevacizumab in the adjuvant setting of HCC, show that the recurrence-free survival benefit seen at the first in patients with hepatocellular carcinoma (HCC) at high risk of recurrence interim analysis is not sustained with longer follow-up. The overall survival data is still immature at the time of this updated analysis. The overall safety profile remains consistent with the first interim analysis. Based on these data, the benefit-risk profile does not support the use of atezolizumab with bevacizumab as an adjuvant therapy for HCC and healthcare professionals are advised against this off-label use. There is no impact on the approved indication of unresectable HCC, where the combination of atezolizumab and bevacizumab remains a treatment option.
Recall of YSP Prednisolone Tablet 5 mg
Retail-level recall of one batch of YSP Prednisolone Tablet 5 mg due to reported presence of blister strip of the Malaysia version of the tablet.
UK
Zolbetuximab Approved to Treat Adults with Stomach or Gastro-oesophageal Junction Cancer
Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them.
A new targeted cancer treatment, given in combination with a standard chemotherapy, for adults with stomach (gastric) or gastro-oesophageal junction cancer has approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The gastro-oesophageal junction is the place where the gullet (oesophagus) joins the stomach.
Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of efficacy in slowing progression of the disease.
As for any new medicine, this decision was made with expert scientific advice on the benefit risk of lecanemab from the Commission on Human Medicines (CHM), the government’s independent advisory body.
