Friday Five – The week in review

New drug approvals galore…

The past week has witnessed a raft of much anticipated new US drug approvals including Roche's multiple sclerosis treatment Ocrevus, Regeneron Pharmaceuticals and Sanofi's moderate-to-severe atopic dermatitis therapy Dupixent, Tesaro's ovarian cancer treatment Zejula and Merck KGaA and Pfizer's PD-L1 inhibitor Bavencio, which has initially been approved by the FDA for the treatment of merkle cell carcinoma. The launch pricing strategies for Ocrevus and Dupixent – which are expected to emerge as the industry's two biggest new drugs in 2017 – are notable.

ViewPoints: Roche fronts up with Ocrevus pricing power

ViewPoints: Regeneron, Sanofi look to 'goldilocks' pricing strategy for Dupixent

ViewPoints: Tesaro secures best-case approval for PARP inhibitor Zejula but AstraZeneca is in hot pursuit

ViewPoints: Bavencio makes commercial landfall but label doesn’t instil confidence on differentiation

One drug not approved by the FDA as scheduled this week was Mylan's generic version of GlaxoSmithKline's asthma and chronic obstructive pulmonary disorder (COPD) treatment Advair; Mylan announced on Wednesday receipt of a complete response letter from the agency, but refused to provide any additional details.

Pfizer secured long-awaited approval for its oral rheumatoid arthritis treatment Xeljanz in Europe (ViewPoints: Pfizer secures long-sought European nod for Xeljanz; but can it compete with Eli Lilly's Olumiant?), and AstraZeneca confirmed approval of its non-small-cell lung cancer (NSCLC) treatment Tagrisso in China, having previously guided towards regulatory clearance by year end. An AstraZeneca spokesperson told FirstWord that high prevalence of the EGFR mutation among the Chinese population appears to have prompted rapid approval of Tagrisso, which is the company's first drug to be approved via the China Food and Drug Administration's (CFDA) priority review pathway. The CFDA also recently approved Boehringer Ingelheim's Gilotrif for a similar indication.

…and more to come

Announcements made this week also point to key drug approvals later in 2017 and into early 2018.

Hot on the heels of FDA approval for Tesaro's Zejula (see above), AstraZeneca confirmed that it has already filed its competing PARP inhibitor Lynparza with the FDA for the maintenance treatment of ovarian cancer in patients who have responded to platinum-based chemotherapy. AstraZeneca's recently reported data for Lynparza in this setting is in germline BRCA mutation patients (Zejula has won a broader label from the FDA), but the company suggests that additional data it has submitted to the agency could result in a label that mirrors that of Tesaro's drug. Lynparza has a PDUFA date in the third quarter.

Novartis confirmed that the FDA has granted priority review to its filing for the CAR-T therapy CTL019 in relapsed/refractory paediatric and young adults with B-cell acute lymphocytic leukaemia. The announcement puts Novartis in a race with Kite Pharma to secure approval for the first CAR-T treatment, albeit in different indications; Kite expects to imminently complete a rolling submission for axicabtagene ciloeucel (formerly KTE-C19) for the treatment of diffuse large B-cell lymphoma – see KOL Views: Updated ZUMA-1 data confirm the time to ramp up commercial operations is now for Kite Pharma, says leading oncologist and Physician Views Poll Results: Oncologists provide broad support for Kite Pharma's CAR-T treatment axicabtagene ciloleucel based on new clinical data.

Vertex Pharmaceuticals announced that two Phase III studies investigating the combination of Kalydeco and tezacaftor for the treatment of certain patients with cystic fibrosis met their primary endpoints, demonstrating significant improvements in lung function versus placebo. While efficacy of the combination appears to be numerically superior to Vertex's marketed therapy Orkambi, safety data is statistically superior. Assuming approval – Vertex plans to file Kalydeco/tezacaftor in the third quarter – launch of the pairing could both replace Orkambi, argue key opinion leaders (KOLs), and provide an alternative therapeutic option for the 20 percent to 30 percent of eligible patients who discontinue treatment with Orkambi due to its safety profile, says Vertex. The positive result also moves the company a step closer to developing a triple therapy, which KOLs hope would deliver a step improvement in efficacy – ViewPoints: Better safe than sorry – Vertex's CF data moves triple combination endgame closer.

The expert view

FirstWord's IAV desk continues to seek out views from KOLs, physicians in the field and other industry experts regarding agenda-setting news events. Recent updates include…

Leading KOL feedback on Nektar Therapeutics' NKTR-181 as a potential game-changer in the long-acting opioid space

Cautiously positive feedback from US-based primary care practitioners who were snap-polled about the same drug

KOL assessment of Jazz Pharmaceuticals' JZP-110, which could emerge as a commercial success story for sleep apnoea, if lingering clinical questions can be resolved

Feedback from US oncologists snap-polled in response to FDA approval of Tesaro's Zejula, suggested that adoption of the drug is likely to occur in ovarian cancer patients regardless of germline BRCA mutation status.

We are also polling US dermatologists about their expected utilisation of Sanofi and Regeneron's newly-approved atopic dermatitis treatment Dupixent and plan to poll US neurologists about Roche's multiple sclerosis treatment Ocrevus, also approved by the FDA this week. We will also be speaking to a KOL to discuss how Ocrevus may dispupt the MS market.

Alexion appoints new CEO

Alexion Pharmaceuticals said Monday that Ludwig Hantson, who most recently served as chief executive of Baxalta, has been appointed as CEO effective immediately. Hantson succeeds interim chief executive David Brennan, who has led the company since December 2016 following the resignation of David Hallal. Whether Hantson's appointment will increase or diminish speculation about Alexion as an M&A play remains unclear – ViewPoints: Alexion’s new CEO a good fit, but will keep speculators guessing.

Gottlieb readies himself for FDA role

US President Donald Trump may have been forced to pull the bill intended to repeal the Affordable Care Act, but his candidate to head up the FDA – Scott Gottlieb – has moved a step closer to the hot seat. Gottlieb is widely considered to be the best choice as FDA Commissioner from the list of other rumoured candidates and a steady pair of hands who has received broad backing from the pharma industry. His ties to the sector remain a cause of some concern in certain quarters, however, and Gottlieb announced this week he will recuse himself for a year from FDA decisions on 20 or more companies in which he has held financial interest or worked as a consultant. According to an ethics agreement with the Department of Health and Human Services, Gottlieb agreed to recuse himself from decisions concerning drugmakers such as Bristol-Myers Squibb, GlaxoSmithKline and Vertex Pharmaceuticals, which previously hired him as a consultant.

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