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2023 Mid-Year Review

BTIG analysts share insights gleaned from tracking medical device clearances, approvals, and FDA review times. COVID-related backlog at FDA had a real impact on medtech approvals there for a while. Now that the pandemic is officially over, are things back to normal for medical device approvals? Medtech analysts at BTIG recently shared some mid-year insights based on multiple years of tracking FDA approval databases. The bottom line: 510(k) clearances are down a bit, PMA approvals are on track to grow substantially, and review times have been mixed depending on the pathway. Through June, there were 1,586 510(k) clearances. At this pace, there would be about 3,075 FDA clearances at the end of the year, representing a 4.4% dip compared to the number of clearances in 2022. The analysts at BTIG noted that it is taking an average of 162.8 days for the agency to render a decision regarding a 510(k) ...
- Source: drugdu
- 200
- July 15, 2023
Urotronic Wins FDA Approval to challenge Boston Scientific, Teleflex for Prostate Market

Dive Brief The U.S. Food and Drug Administration has approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), the company announced Tuesday. BPH is defined by the expansion of the prostate. As the organ grows, it can cause changes in the bladder that result in lower urinary tract symptoms such as leaking urine. Urotronic’s newly approved Optilume BPH catheter system is designed to tackle the symptoms through mechanical dilation and the delivery of paclitaxel to stop the problem from recurring. Dive Insight Researchers studied the use of balloon dilation in BPH in the 1990s, but the technique failed to provide long-term benefits. Urotronic has tried to address that problem by pairing the immediate symptomatic relief provided by balloon dilation with localized delivery of paclitaxel, a drug that is already widely used in cardiovascular devices to prevent blood vessels from narrowing after ...
- Source: drugdu
- 120
- July 15, 2023
Takeda Withdraws Dengue Vaccine Application After FDA Request for More Data

Takeda has voluntarily withdrawn the Biologics License Application for its dengue vaccine candidate TAK-003 following discussions with the FDA regarding additional data collection, the Japanese pharma company announced Tuesday. According to Takeda, it will not be able to address the regulator’s concerns within the current BLA review cycle. The company is currently assessing its future options and plans for TAK-003, as well as evaluating the requirements for a potential BLA resubmission in the U.S., a spokesperson told Fierce Pharma. The FDA accepted Takeda’s BLA for TAK-003 in November 2022 and put the application under Priority Review, which typically results in a decision within six months versus the standard 10-month review period. “We will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.,” Gary Dubin, president of Takeda’s vaccines business unit, said in a statement. TAK-003 is a tetravalent live-attenuated vaccine ...
- Source: drugdu
- 124
- July 14, 2023
FDA Clears More Chemotherapy Imports from China’s Qilu Amid Shortage of Key Cancer Meds

As a shortage of key chemotherapy drugs continues to upend cancer treatment across the country, the FDA has resorted to securing some of the meds from China.After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. Canada’s Apotex will distribute the drugs, which are expected to arrive this week, a company spokesperson told Fierce Pharma. Apotex is “very pleased” to aid in addressing the shortage, the spokesperson added. Cisplatin, along with fellow platinum-based chemotherapy carboplatin, are commonly used as a standard of care across many types of cancer. The newest import was first reported by Bloomberg. After the FDA flagged quality issues at a facility that produced the drug, a “ripple effect” ensued across the supply chain, the FDA’s Oncology Center of Excellence chief Richard Pazdur, M.D., told The Cancer ...
- Source: drugdu
- 103
- July 14, 2023
FDA Rejects Xspray’s Would-Be Rival to Bristol Myers’ Sprycel on Dosing, Manufacturing Concerns

With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
- Source: drugdu
- 205
- July 13, 2023
FDA Puts Clinical Hold on Hemogenyx’s CAR-T AML Therapy

The FDA has placed a clinical hold on Hemogenyx Pharmaceuticals’ investigational HEMO-CAR-T, which is being trialed for the treatment of acute myeloid leukemia (AML), the UK-based biotech announced Monday. In its full review letter, the FDA pointed to manufacturing problems as the reason for the regulatory pause. In particular, the regulator flagged a “splicing deficiency” that arises during the production of the lentivirus that is used to create the CAR-T cells for Hemogenyx’s candidate, according to the company’s press release. Hemogenyx has already found the source of the splicing issue and has come up with a method to solve it. CEO Vladislav Sandler said in a statement that the company is “confident” that it will “be able to address the FDA’s questions and concerns” regarding HEMO-CAR-T’s Investigational New Drug (IND) application. The company submitted its IND seeking to launch a Phase I trial for HEMO-CAR-T in May 2023. In its letter to Hemogenyx, the ...
- Source: drugdu
- 144
- July 12, 2023
CMS Expands Medicare Coverage for Leqembi After FDA Traditional Approval

Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
- Source: drugdu
- 131
- July 11, 2023
Astellas Gains FDA Priority Review for Gastric Cancer Therapy BLA

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients. Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive. Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients. A decision on the approval by the regulatory agency is anticipated on 12 January 2024. The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings. Zolbetuximab was assessed along with a regimen comprising oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial. The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX). Astellas immuno-oncology development ...
- Source: drugdu
- 121
- July 11, 2023
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 109
- July 9, 2023
FDA grants orphan drug designation to ImPact’s focal cancer therapy

The US Food and Drug Administration (FDA) has granted an orphan drug designation to ImPact Bio’s padeliporfin vascular targeted photodynamic therapy (VTP) for patients with locally advanced pancreatic cancer. Israel-headquartered ImPact Bio expects to submit an investigational new drug application (IND) later in 2023, with a Phase I trial of the treatment in patients with locally advanced pancreatic ductal adenocarcinoma also scheduled for this year, per a 5 July press release. Orphan drug designations come with certain benefits such as granting tax credits for US-based clinical trials and recommendations from the FDA on the required clinical and preclinical studies. Padeliporfin VTP is based on the combined use of the drug padeliporfin and non-thermal laser light. The drug is administered intravenously to a patient after which it is activated by a non-thermal laser light in the specific area of the tumour, per the company’s website. The light results in the drug’s ...
- Source: drugdu
- 105
- July 8, 2023

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