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

USA

FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C. The test may be performed in settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics. Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.

FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review

The U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. The two authorized ACE products are sealed, pre-filled, non-refillable pods that are used with the previously authorized ACE device, and the two authorized DAILY products are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir.

FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy The U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.

EUROPE

First nasal adrenaline spray for emergency treatment against allergic reactions

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis).

EMA recommends revoking conditional marketing authorisation for Ocaliva

EMA’s human medicines committee (CHMP) has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its benefits are no longer considered to outweigh its risks. Ocaliva is used to treat adults with primary biliary cholangitis (PBC), an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.

EU actions to tackle shortages of GLP-1 receptor agonists

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to tackle shortages of the glucagon-like peptide-1 (GLP-1) receptor agonists Ozempic (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Victoza (liraglutide). GLP-1 receptor agonists are authorised for the treatment of diabetes or for weight management under certain conditions or both.

EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna is used in patients whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk.

Review of painkiller metamizole started

EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough.

Metamizole-containing medicines are authorised in a number of EU countries for treating moderate to severe pain and fever.

EU recommendations for 2024/2025 seasonal flu vaccine composition

EMA has issued recommendations for the influenza virus strains1,2 that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024.

AUSTRALIA

Proactive monitoring of highest-risk medical device clinical trials

We are reviewing the safety information supporting notifications of the highest-risk implantable and cardiac invasive medical devices used in first-in-human clinical trials.

PIC/s Guide to Good Manufacturing Practice (GMP): manufacturing principles for medicines, APIs and sunscreens

The Minister for Health and Aged Care to determine Manufacturing Principles – Therapeutic Goods (Manufacturing Principles) Determination- external site – that must be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients (API) and sunscreens, at Australian manufacturing sites.

MALAYSIA

Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum

Rituximab, obinutuzumab, ofatumumab, and ocrelizumab are anti-clusters of differentiation 20 (CD20) antibodies used to deplete B cells (also known as B lymphocytes) in diseases characterised by overactive, dysfunctional, or malignant B cells.1-6 These include cancers like chronic lymphocytic leukemia (CLL) and follicular lymphoma, as well as autoimmune diseases such as relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Anti-CD20 antibodies specifically target CD20, a cell surface antigen on B cells, and destroy B cells through several mechanisms.

In Malaysia, there are currently 7 products containing rituximab, and 1 each containing obinutuzumab, ofatumumab, and ocrelizumab, that have been registered with the Drug Control Authority (DCA).

SINGAPORE

Design update to the Ascenda™ Intrathecal Catheter – Models 8780, 8781 and 8784 (part of the Medtronic Synchromed™ II Programmable Drug Infusion System)

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of a design update to the Ascenda™ Intrathecal catheter models 8780, 8781, and 8784, which are part of the Medtronic Synchromed™ II Programmable Drug Infusion System. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion. Presence of tissue in the catheter connector may result in a prolonged surgical procedure due to extended troubleshooting (i.e., cleaning and re-attaching the connector or replacing the pump connector). If the presence of tissue in the catheter connector causes an obstruction, it may lead to return of symptoms, loss of therapy and/or life-threatening baclofen withdrawal. Healthcare professionals are advised to ensure that the Ascenda catheter is completely connected to the pump through proper alignment and full engagement of the catheter connector to the catheter port on the pump. Medtronic is not recommending prophylactic replacement of currently implanted Ascenda catheters due to the low observed occurrence rate (0.06%) and the risks associated with replacement surgery. Instead, Medtronic recommends re-emphasising to patients and caregivers the signs and symptoms of withdrawal or return of underlying conditions.

Recall of Maltofer Drops (Iron) 50 mg/ml

The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy.

Voluntary recall of specific lots of Coated VICRYL™ Plus Antibacterial (polyglactin 910) Suture A Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte. Ltd. to inform healthcare professionals of a voluntary recall of specific lots of Coated VICRYL™ Plus Antibacterial (polyglactin 910) Suture. A manufacturing issue on a specific packaging machine has resulted in a hole in the primary packaging of a small percentage of sutures manufactured between 27 January and 27 March 2024. This breach in sterility may introduce pathogens to patients and cause infections requiring medical interventions. The sutures may also have compromised physical properties leading to treatment failure. Healthcare professionals are advised to identify, quarantine and return all unused affected products. Those who have treated patients using these affected products should follow the patients post-operatively in the usual manner with no additional action required.