Pharmaceutical Technology Editors

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced that Kapruvia (difelikefalin) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) as a treatment for moderate-to-severe pruritis associated with chronic kidney disease (CKD) in adult hemodialiysis patients.

The Swiss approval of Kapruvia, which was revealed in an Aug. 19, 2022 press release, follows on from the approval in the United States, Europe, and United Kingdom, as well as Canada. Swissmedic’s decision was supported by positive data from two Phase III clinical trials and an additional 32 clinical studies.

“The approval of Kapruvia in Switzerland is the next step on our journey to bring this breakthrough treatment to hemodialysis patients living with CKD-associated pruritus around the world,” said Klaus Henning Jensen, chief medical officer of CSL Vifor. “There is a high unmet medical need for a targeted therapy to treat moderate-to-severe pruritus, and we are convinced that Kapruvia can provide relief to many suffering from this heavy burden. We are very committed to making this therapy available to patients as soon as possible.”

“We are pleased that Kapruvia is now approved in Switzerland for hemodialysis patients who are suffering from CKD-associated pruritus,” said Christopher Posner, president and CEO of Cara Therapeutics. “As Cara Therapeutics continues on the path toward becoming the leader in the treatment of chronic pruritus, we are working with our partner VFMCRP to ensure this first-of-its-kind therapy is available to healthcare providers and patients across the globe who greatly need a treatment option.”

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Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.

Treatment for Moderate-to-Severe CKD-Associated Pruritus Gains Swiss Approval

Celltrion Healthcare announced, in an Aug. 19, 2022 press release, that the European Commission (EC) has approved Vegzelma (CT-P16), its biosimilar to bevacizumab referencing the European Union (EU)-approved Avastin.

The approval covers the use of Vegzelma in the treatment of European patients with metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer. EC’s decision follows on from the recommendation for marketing authorization that was issued by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

“The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price,” said Kevin Byoung Seo Choi, senior vice-president and head of Marketing Division at Celltrion Healthcare, in the press release. “With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year.”

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare

The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally, whereby innovators are mapping out a product’s full lifecycle as early as the pre-clinical stage.

According to an Aug. 19, 2022 press release, a key finding published in the report is that ‘pharma-ready’ synthetic routes are being planned much earlier in the development process, with ‘phase-appropriate development’ being believed to be an outdated approach, particularly when dealing with accelerated pathways. It is suggested in the report that innovators will need to choose either a single end-to-end provider or a multi-provider model and that contract development and manufacturing organizations (CDMOs) will need to rethink their approaches to development and marketing.

“This report highlights that innovators need to meet contract services partners sooner, plan much earlier and far further into development,” said Orhan Caglayan, brand director at CPHI Frankfurt, in the press release. “We are evolving CPHI Frankfurt to help both CDMOs and innovators adapt to this shift in approach by providing new insights and more networking opportunities for early-stage companies attending the event. Over the next few years, we anticipate many more biotechs will use CPHI to map out their potential partners long before IND. Exploring what type of outsourcing approach will best fit their products development and even commercial needs.”

The full report is available for download.

The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally.

CPHI Report Predicts Significant Shifts in Global Outsourcing Strategies

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for the oral fixed-dose combination treatment (decitabine and cedazuridine [ASTX727]) as an initial treatment for adults with acute myeloid leukemia (AML). The decision was announced in an Aug. 22, 2022 press release from Otsuka Pharmaceutical Europe and Astex Pharmaceuticals.

Currently, the standard of care for patients with AML is hospital-administered intravenous (IV) chemotherapy infusions or parenterally administered hypomethylating agents. If the oral combination treatment of decitabine and cedazuridine is approved, it would become the first and only oral hypomethylating agent licensed in the European Economic Area for the initial treatment of patients with AML who are ineligible for intensive chemotherapy.

Results from the Phase III ASCERTAIN clinical trial, which investigated the pharmacokinetic (PK) exposure equivalence of the combination therapy versus IV decitabine, have provided support for the MAA. The primary endpoint of the study was met, whereby the combination therapy showed exposure equivalence to a standard five-day regimen of IV decitabine, and the safety profile of the combination therapy was generally consistent with the comparator therapy.

In December 2021, the combination therapy was granted orphan drug designation by the European Commission and in April 2022, EMA agreed to a Paediatric Investigation Plan for the combination therapy, which is an important milestone for the further clinical evaluation in children with AML.

EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.

EMA Starts Review of Oral Fixed-Dose Combination Treatment for AML

Grand River Aseptic Manufacturing (GRAM), a parenteral drug product contract development and manufacturing organization (CDMO), announced the completion of Phase II of its facility expansion on Aug. 17, 2022.

The expansion includes the installation of GRAM’s two new sterile Bausch+Ströbel filling lines. One is a modular vial and syringe/cartridge fill line with SKAN isolator, and the other is a high-speed vial fill line with SKAN isolator. According to a company press release, they are identical in technology to the company’s previously installed fill line with IMA lyophilizer, which began manufacturing product in September 2020. GRAM’s filling capacity now reaches over 50 million units per year.

GRAM’s aseptic filling facility is designed with independent formulation and filling suites. In addition to completing Phase II, GRAM has significantly progressed Phase III of their facility expansion, which will offer more filling and finishing capacity.

“GRAM has assembled a team of experts within our company to serve new and existing partners on industry-leading equipment that elevates the breadth of what a CDMO can provide,” said Tom Ross, president and CEO of Grand River Aseptic Manufacturing, in the press release. “Continuity of technology across all our fill lines benefits our clients as their products transition from the clinic to the market. The capabilities established at GRAM with new facilities and equipment will better serve our clients focused on high-value biologic drug products. We are excited and ready to offer top-of-the-line solutions to the marketplace and entertain even more guests here in Grand Rapids.”

Grand River Aseptic Manufacturing has completed phase II of its facility expansion with the installation of two new sterile filling lines. 

Grand River Aseptic Manufacturing Completes Phase II of Facility Expansion

ProBioGen announced on Aug. 17, 2022 that it has closed a Master Service Agreement with NextPoint Therapeutics to initiate development and good manufacturing practice manufacturing of its lead antibody candidate.

ProBioGen’s CHO RIGHT cell line development, including their DirectedLuck transposase and platform processes, enable the development to provide a high-expressing stable cell line and a robust manufacturing process. According to the press release, ProBioGen’s proprietary cell culture medium makes is designed to improve protein titers and cell growth behavior.

"We are proud NextPoint has selected us for this fast-track [chemistry, manufacturing, and controls] development and manufacturing of its unique antibody that targets a novel immune checkpoint axis offering promise for hard to treat cancers,” said Gabriele Schneider, Chief Business Officer, ProBioGen, in the press release. “We are thrilled to support them with our expertise and technology to move this candidate towards the clinic.”

ProBioGen will collobarate with NextPoint Therapeutics  to develop and manufacture its lead antibody candidate.