Product Development

GSK’s closed triple in COPD faces pulmonologist resistance on ICS use but GP generous prescribing to drive market

GlaxoSmithKline’s (LON:GSK) closed triple FF/UMEC/VI combination carries dampened enthusiasm for use in chronic obstructive pulmonary disease (COPD)with questionable risk/benefit profile of the inhaled corticosteroid (ICS), experts said.

The closed triple is a once-daily inhaler with an inhaled corticosteroid (ICS)/long acting muscarinic antagonist (LAMA)/ long acting beta agonist (LABA) combination of GSK’s Flovent (fluticasone), Incruse (umeclidinium) and vilanterol, respectively.

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BioMarin’s pegvaliase for PKU will likely remain second to Kuvan at initial launch, eventual uptake certain with unmet need, diet noncompliance – experts

BioMarin Pharmaceutical's (NASDAQ:BMRN) PEG-PAL (pegvaliase) if approved has most experts noting that it will initially remain second-line as an option for adult standard of care (SOC) for phenylketonuria (PKU) versus Kuvan (sapropterin). Kuvan’s preferable side-effect profile and physician experience, among other reasons, will have it maintain its first-line status, they said.

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AstraZeneca’s KESTREL head and neck cancer study has decent chance of positivity for durvalumab/tremelimumab – experts

AstraZeneca’s (LON:AZN) Phase III KESTREL study of durvalumab/tremelimumab has potential to show extended survival in patients with first-line recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), experts said.

Phase I durvalumab monotherapy data lends confidence in the combination’s ability to improve survival over the SOC regimen of Eli Lilly’s (NYSE:LLY) Erbitux (cetuximab)/5-FU/platinum chemotherapy (EXTREME), albeit with some reservations about potential toxicity, experts said.

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Legislation to force payer coverage of abuse-deterrent opioids faces resistance due to cost barriers; limited data to support benefit– experts

Proposed legislation across 23 US states to force payers to increase reimbursement of abuse-deterrent (AD) opioids will likely face significant resistance due to state cost implications, most experts said. The state payer- Medicaid- and private payers alike will likely argue that AD opioids do not currently have enough evidence to support the idea that they prevent abuse and addiction, experts added.

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Fibrogen could face IPF strategic conundrums to keep post-Phase IIb pamrevlumab pursuit viable - experts

Fibrogen (NASDAQ:FGEN) faces hurdles to advance pamrevlumab in idiopathic pulmonary fibrosis (IPF) beyond its Phase IIb results, experts said. Fibrogen may struggle to execute a robust randomized trial and may be hoping for acquisition interest after releasing Phase IIb data, a source said, while a pulmonologist who was familiar with company strategy pointed to its struggles after the 2014 approvals of...

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Roche’s emicizumab’s Phase III trial in haemophilia A has most experts questioning drug overall safety profile, clinical future unclear

Roche’s (VTX:ROG) report of a patient death in its Phase III ACE910 (emicizumab) HAVEN 1 study in haemophilia A had experts question a trial investigator’s claim the death occurred independently of the drug.

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Cidara's Phase III candidiasis trial primed for approval; CD101 uptake triggers largely positive expert feedback

Cidara Therapeutics’ (NASDAQ:CDTX) suggested future Phase III trial design investigating intravenous (IV) CD101 for candidiasis is well-designed to demonstrate noninferiority compared with standard of care (SOC), experts said. CD101’s superior dosing schedule is likely to see it take a significant slice of the existing antifungal market, most added.

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Amgen’s high LDL-C drug Repatha’s Phase III CVOT success has uncertain clinical and payer relevance ahead of full trial read outs – experts

Unclear clinical relevance remains for Amgen’s (NASDAQ:AMGN) Phase III of its high LDL-C drug Repatha's (evolocumab) cardiovascular outcomes trial (CVOT), experts said, despite the company calling the study a success with a significant reduction in CV events.

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Spark has experts envisioning an amortized payment plan for voretigene in RPE65-mediated IRDs

Spark Therapeutics’ (NASDAQ:ONCE) voretigene neparvovec will most likely see an amortized payment plan from payers if approved regardless of its label, experts said. Analysts have stated that Spark’s therapy has shown promising four-year durability from the Phase I study, which could support a one-time upfront cost and wide uptake, with global sales of USD 573 million expected in 2023.

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AstraZeneca’s durvalumab/tremelimumab strikes Phase III efficacy optimism for unselected first-line NSCLC patients with data, MOA rationale- experts

AstraZeneca’s (LON:AZN) durvalumab/tremelimumab combination for first-line non-small-cell lung cancer (NSCLC) has a good chance of beating standard-of-care (SOC) chemotherapy in a Phase III trial, most oncologists said. Based on past data and the mechanism of action, the addition of tremelimumab is likely to increase the objective response rate (ORR) in an unselected population, which increases survival prospects, they explained.

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