Tower Mains Weekly Newsletter
Regulatory Updates
Revised Annex 1 Becomes Effective
As of 25th August, the Annex 1 revision is finally operational, manufacturers in the EU must be compliant with the GMP guideline updates. Revision to the document has been made to reflect changes in regulatory and manufacturing environments. The new guideline clarifies how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines.
FDA Guidance Updates
On 28th August, the US Food and Drug Administration issued Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act–Compliance Policies guidance. This guidance is directed to manufacturers, wholesale distributors, dispensers, and repackagers who are subject to requirements for enhanced drug distribution security under section 582(g)(1). The FDA believes the guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct electronic tracing at the package level, to achieve robust supply chain security.
MHRA Updates
On 29th August, the Medicines and Healthcare products Regulatory Agency (MHRA) announced three (3) new UK Approved Bodies: TÜV SÜD, Intertek, and TÜV Rheinland UK joining the current UK Approved Bodies.
Regulatory Authorities Conduct Review of Data on Paternal Exposure to Valproate
Following the lead from the MHRA and the European Medicines Agency (EMA), Swissmedic is investigating whether the use of the drug valproate by fathers is tied to neurological birth defects in their children.
Several regulatory authorities are reviewing data on the risk of neurological development disorders in children conceived by fathers taking valproate.
Industry Updates
Sandoz’s Tyruko Biosimilar Granted FDA Approval
On 25th August, Sandoz, a global leader in generic and biosimilar medicines, that the US FDA approved their biosimilar Tyruko® (natalizumab-sztn), Tyruko® is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis.
Administered as an injection, it was approved as a monotherapy to treat all indications for relapsing forms, including clinically isolated syndrome, relapsing-remitting and active secondary progressive disease, as well as Crohn’s disease.
ImmunoGen Collaborates with Takeda to Develop ELAHERE® in Japan
On 28th August, ImmunoGen, a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, announced it had entered into an exclusive collaboration with Takeda Pharmaceutical to develop and commercialize ELAHERE (mirvetuximab soravtansine-gynx) in Japan.
Novartis Reveals New Long-term Leqvio® (Inclisiran) Data
On 28th August, Novartis revealed new long-term data from its ORION-8 clinical trial. The study is a phase III open-label extension of the company’s ORION-9, ORION-10, ORION-11 and ORION-3 trials. Data emerging from the research has shown that incorporating twice-yearly dosing of the drug – in addition to statin therapy – provides consistent low-density lipoprotein cholesterol reduction beyond six years. The treatment involves individuals with atherosclerotic cardiovascular disease (ASCVD), an increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH). ORION-8 has been the most expansive study to date and continues to analyse the safety profile, long-term efficacy and tolerability of the candidate. In total, there has been an exposure of more than 8,500 patient-years during the trial’s three-year follow-up.
AbbVie Submits Applications For Risankizumab to FDA and EMA
On 28th August, AbbVie announced that it has submitted applications for a new indication to the US FDA and EMA for risankizumab (SKYRIZI®, 1200 mg intravenous [and 180 mg and 360 mg subcutaneous for the treatment of adult patients with moderately to severely active ulcerative colitis. AbbVie’s applications are supported by results from two Phase III clinical trials, including INSPIRE, an induction study; and COMMAND, a maintenance study.
The primary endpoint of clinical remission was met in patients who received risankizumab 1,200mg intravenously at week 12 in the induction study, and 180mg or 360mg subcutaneously at week 52 in the maintenance study. Patients treated with risankizumab in both studies achieved the key secondary endpoints of endoscopic improvement as compared to placebo.
FDA Grants Orphan Drug Designation to Faron’s Bexmarilimab
On 29th August, Faron Pharmaceuticals, a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announced that the US FDA had granted Orphan Drug Designation (ODD) to its wholly-owned asset bexmarilimab, for the treatment of acute myeloid leukemia. This will lead to clinical development and commercialisation benefits that will ultimately strengthen the drug programme, the drug is currently in a phase I study where it is being tested for the treatment of aggressive haematological malignancies, phase II expected to start at the end of 2023.
Roche’s Tecentriq® Granted MHRA Approval
On 29th August, Roche announced that Tecentriq® SC (atezolizumab) had been approved by the MHRA, it will be provided by the National Health Service (NHS) England. This will be the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in the UK. Administration of the drug takes approximately seven minutes compared to 30-60 minutes via intravenous administration.
EC Approves KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction
On 29th August, Merck, known as MSD outside of the United States and Canada announced that the European Commission (EC) approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).
Issue Number: WN00127
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