David Frabotta

Circassia Pharmaceuticals and AstraZeneca collaborated to win regulatory approval of DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

DUAKLIR PRESSAIR is a fixed-dose LAMA/LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. It is administered twice daily via the pre-loaded, breath-actuated, PRESSAIR multi-dose inhaler. The product is approved worldwide, including in the European Union, under a number of brand names.

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Circassia and AstraZeneca established a commercial collaboration in 2017 in the United States, where Circassia has exclusive U.S. commercialization rights and AstraZeneca is responsible for the product’s development and regulatory submission.

“The FDA approval of DUAKLIR PRESSAIR gives COPD patients a new, effective and safe option in LAMA/LABA therapy, enabling them to receive maximal improvement in lung function delivered through a unique dry-powder inhaler,” said Michael Asmus, Vice President, U.S. Medical Affairs, Circassia.

COPD is the third leading cause of death in the United States; more than 11 million people have been diagnosed with COPD, but millions more may have the disease without knowing it, according to the American Lung Association. COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.

See more information on clinical trials, indications, safety information, and full prescribing information 

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DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) provides LAMA/LABA therapy.

FDA Approves New COPD Maintenance Treatment

The U.S. Environmental Protection Agency passed new hazardous waste pharmaceutical disposal rules that ban sewering, but the approved regulations allow some flexibility for drugs that can be redistributed or that qualify for manufacturer credit.

 part 266 subpart P, go into effect in August with variable implementation deadlines by state. Healthcare facilities will be able to accumulate hazardous waste pharmaceuticals onsite without a Resource Conservation and Recovery Act permit for 365 days, an increase from 275 days in the current regulation. The rule also removes over-the-counter nicotine replacement therapies from the acute hazardous waste listing, thereby classifying it as non-hazardous waste.

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Pharmacies and healthcare facilities will not be classified as a large-quantity generators when they create more than 1 kilogram of acute hazardous waste pharmaceuticals in one month, and thus will not need to comply with satellite accumulation area regulations.

In a welcomed and unusual departure from ubiquitous paperwork, pharmacies will not need to specify hazardous waste codes on manifests, will not need to keep track of how much hazardous waste is generated each month, nor need to segregate acute and non-acute hazardous waste pharmaceuticals.

The definition of hazardous waste pharmaceuticals are established in 

 part 261.2 subpart C and D. Two major exceptions are if a pharmaceutical can be lawfully donated or reclaimed, and OTC products that have reasonable expectations of lawful reuse or redistribution. Drugs that do not have a reasonable expectation to be eligible for manufacturer credit, a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be reused, dietary supplements, and homeopathic drugs must be disposed of by a hazardous waste treatment, storage, and disposal facility, including:

free samples of pharmaceuticals received by healthcare facilities;

residues of pharmaceuticals remaining in empty containers;

contaminated personal protective equipment;

clean-up material from the spills of pharmaceuticals.

With regulations in tow this summer, pharmacies will need to check state law and state regulatory activity to determine compliance deadlines before the federal deadline in August. Subpart P compliance deadlines will include a one-time notification. All personnel wil need to be trained on non-creditable hazardous waste pharmaceuticals, and a system will need to be created to determine whether drugs are creditable or non-creditable, and storage protocols will need to be established for each category and also distinguish between prescription and non-prescription products. Storage cannot exceed 365 days onsite, and healthcare facilities must adhere to labeling requirements, container standards, and shipping standards.

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EPA also passed new empty container standards for dispensing bottles, syringes, IV bags, and other acute and non-acute hazardous waste pharmaceuticals. One notable change is a ban on triple rinsing containers with acute hazardous waste.

Exemptions exist for DEA controlled substances, which must be managed in compliance with DEA regulations and destroyed by a method that meets the agency’s non-retrievable standard, including approved waste combustors or incinerators.

Approved regulations allow for some flexibility for drugs that can be redistributed or qualify for manufacturer credit. 

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The Food and Drug Administration granted accelerated approval to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Janssen has selected US Bioservices to dispense the drug.

Patients should be screened using an FDA-approved companion diagnostic for erdafitinib: The FDA also approved the therascreen FGFR RGQ RT-PCR Kit, developed by QIAGEN, for use as a companion diagnostic for this therapeutic indication.

Erdafitinib approval was based on data from a cohort of 87 patients enrolled on Study BLC2001 (NCT02365597), a multicenter, open-label, single-arm trial. These patients had locally advanced or metastatic urothelial carcinoma that had progressed on or after at least one prior chemotherapy and had certain FGFR3 gene mutations or FGFR2 or FGFR3 gene fusions. Patients received erdafitinib at a starting dose of 8 mg once daily with a dose increase to 9 mg daily in those whose serum phosphate levels were below the target of 5.5 mg/dL, between days 14 and 17. The starting dose was increased to 9 mg daily in 41% of the patients. Erdafitinib was administered until disease progression or unacceptable toxicity.

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“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today’s approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs.”

The most common type of bladder cancer is transitional cell carcinoma, also called urothelial carcinoma. Bladder cancers are associated with genetic mutations that are present in the patient's bladder or entire urothelium (the lining of the lower urinary tract). Bladder cancer is the sixth most common cancer in the United States. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer. In 2018, an estimated 81,190 new cases of bladder cancer are expected, resulting in 17,240 deaths, and the five-year survival rate is 5%, according to New Jersey-based Johnson & Johnson, parent company of Janssen

“For patients diagnosed with urothelial cancer, outcomes are unfortunately disheartening due to the aggressiveness of the disease,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “Through the continued development of erdafitinib, and working closely with the FDA, we look forward to bringing a potential new treatment option to patients.”

Urothelial cancer, also known as transitional cell cancer, is the sixth most common type of cancer in the U.S. These cancers start in the urothelial cells that line the inside of the bladder. In 2018, an estimated 81,190 new cases of bladder cancer are expected, resulting in 17,240 deaths.4 For patients with metastatic disease, outcomes can be dire due to the often rapid progression of the tumor and the lack of efficacious treatments, especially in relapsed or refractory disease. The relative five-year survival rate for patients with metastatic disease is five percent.

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The major efficacy outcome measure was objective response rate (ORR) as determined by blinded independent review committee according to RECIST 1.1. ORR was 32.2% (95% CI:22.4, 42.0), with complete responses in 2.3% and partial responses in 29.9%. Median response duration was 5.4 months (95% CI: 4.2, 6.9). Responders included patients who had previously not responded to anti PD-L1 or PD-1 treatment.

Erdafitinib can cause ocular disorders. Central serous retinopathy or retinal pigment epithelial detachment resulting in visual field defect was reported in 25% of patients. The most common adverse reactions reported in at least 40% of patients were increased serum phosphate, stomatitis, fatigue, increased serum creatinine, diarrhea, dry mouth, onycholysis, increased alanine aminotransferase, increased alkaline phosphatase, and decreased sodium.

The recommended initial dose of erdafitinib is 8 mg orally once daily (with or without food) with a dose increase to 9 mg daily if criteria are met.

View full prescribing information for BALVERSA

Erdafitinib is first targeted therapy for FGFR3 or FGFR2 genetic alteration.

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Hospital and health system pharmacists have a new tool to help predict when opioid diversion might occur, and who might be doing it. Global medical technology company BD unveiled BD HealthSight Diversion Management, a cloud-based application that mines data from its other hospital management software to identify theft and create investigative workflow to monitor, triage, and assign potential diversion cases.

BD HealthSight uses Microsoft-driven AI and data-science methodologies to analyze data points-such as overrides, canceled transactions, delays in dispensing, administering and wasting medications-from BD’s electronic medical record and medication dispensing systems. It then generates reports that automatically flag suspect behaviors.

Drug Topics discussed the rollout with Ranjeet Banerjee, worldwide president of Medication Management Solutions for BD, during the ASHP Midyear Meeting earlier this month.

Tell me about why BD developed this tool for hospitals:

: The opioid problem is well known; 130 people die every day, and that is an improvement from recent years. One aspect of the opioid crisis is the fact that drug diversion happens in hospital settings, and it is slowly becoming clear that diversion is part of the problem. We have technologies that focus on medication management across the healthcare setting. Some are looking for solutions and patterns to detect diversion early and stop it from happening. This is a huge patient safety issue as well as a financial one for health systems.

DT: Was this something you identified as a critical need for healthcare systems, or was it initiated by your clients who needed a solution for diversion?

: It was a combination of both. This problem started to bubble up, and we started to think about how we could do something unique given our penetration with our current platforms. First, we have a solid vantage point in almost two-thirds of hospitals in the country where we have some system for medication management. And we knew that you cannot solve this problem without a capability that is always changing so people can’t override it. Our system uses AI to learn and change. Second, we collaborated with our customer base to understand how the report can fit into workflows. And third, we established a community of users to help us create a repository of diversion techniques so the system has a framework to learn from.

Q: What are some of those inputs that help build the framework?

: The data being analyzed is already there. For example, we know traveling nurses can be one risk area of diversion. But in order to react to a situation, hospitals and health systems must pull different data points [work logs, dispensing logs, and patient records] manually and analyze it manually, which is highly inefficient, highly inaccurate, and has no clear outcomes. We’ve developed a way to use AI and Microsoft analytics to identify signals [behaviors, circumstances, and other data points] that lead to diversion in a way that makes the information usable. We are focusing on signals that lead to opioid diversion right now, but we’ve spotted signals for other meds as well, so there is broader applicability. 

Q: Can additional data points be included from outside sources, like criminal records?

: Right now, the only inputs come from the health system records. The benefit of the system is that we are now connecting all the disparate systems on the same platform so that the AI can analyze the data so it can be used by the staff in real time. There are many things we are considering for subsequent versions, but in the meantime, this application connects the hospital data points into one platform with analysis tools. This kind of medication inventory optimization is a win for the patient, the hospital, and society.

Health systems employ Artifical Intelligence and integrated medication management to address diversion.

Author | David Frabotta

Articles

FDA Approves New COPD Maintenance Treatment

EPA’s New Rules on Drug Disposal Begin in August

Balversa Fast-Tracked for Bladder Cancer

BD Unveils New Tool to Fight Opioid Crisis