Launch and COVID-19: Pharma’s Dilemma

How will COVID-19 affect regulatory approvals in the US and EU?

COVID-19’s impact on pharma is continually evolving. All insights expressed here were formulated based on the situation as of April 14, 2020.

Whilst both the FDA and the EMA have signaled a commitment to continuing day to day activities and flexibility in how advisory and committee meetings may function virtually, we are still seeing short-term postponements taking place. Planned meetings for April and May have been rescheduled by the FDA for June and new PDUFA dates have now been announced. Products affected by these changes include Roche’s risdiplam in spinal muscular atrophy (SMA) and Intercept’s obeticholic acid in non-alcoholic steatohepatitis (NASH).

Roche Logo

Roche’s oral spinal muscular atrophy drug risdiplam currently bears an FDA decision date for May. On April 7th, Roche announced that the FDA delayed its PDUFA by 3 months from May 24th to August 24th.

The FDA will likely feel less urgency to review the drug if its resources are under pressure, given there are already Novartis’ gene therapy Zolgensma and Biogen’s tried-and-true Spinraza on the market.

Intercept has been gearing up for the potential launch of OCA (obeticholic acid) in liver fibrosis due to NASH, but now stands to wait a bit longer.

The Advisory Committee Meeting, previously scheduled for April 22nd, is now tentatively rescheduled for June 9nd, with the PDUFA date remaining the same for June 26th.

The FDA has suggested multiple options for conducting virtual reviews, however as of April 13th it has not scheduled a virtual advisory committee. Some applicants may choose to delay in favor of having an in-person meeting due to concerns surrounding robustness of presentation impact and a lack of interactivity potentially affecting review outcomes. Further questions remain about whether the FDA can maintain its typical pace assessing applications. long-term separation among agency colleagues, travel restrictions for site inspection, and administrative prioritization of pandemic-related efforts could result in slower agency output. Officially, the FDA has not signaled any specific impact on existing user fee goals, but products with fee goals between April and July (of which there are 48 in total) are most likely to be impacted.

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How is launch performance likely to be impacted?

Changes to how medicine is practiced during the pandemic, as well as an upending of the promotional and educational activities usually undertaken, create challenges for products set to launch in the coming months. These challenges include:

In-office visits to HCPs are limited, making it more difficult to educate or address concerns for new product/indication launches

HCPs are treating fewer patients during the pandemic, which means fewer opportunities for a new prescription

HCPs’ focus is elsewhere, making it challenging to effectively communicate messaging

HCPs may be more risk-averse and hesitant to try new products at this time, especially given the challenges of limiting in-person meetings with patients

In-person conferences are being rescheduled or made virtual, presenting obstacles to effective communication with key medical and commercial stakeholders

These challenges will be most acutely experienced by products launching in a competitive space where satisfactory alternatives exist, as well as products from small-cap biotechs with less marketing experience and smaller promotional budgets. On the flipside, drugs for life-threatening diseases that have few other options on the market would be more protected from launch disruption. In most cases we expect launches are likely to underperform relative to pre-pandemic expectations, with a much flatter uptake curve expected over the next 6 months.

How are companies with planned or recently initiated launches responding?

Whilst we are likely to see some delay in launches in April and May as pharma grapples with disruptions to normal commercial and promotional activities, we expect many companies will resist more significant delays to their launch plans. Why? Because the patent clock is still ticking and there is little certainty around when disruptions affecting the launch environment will improve.

Products highly reliant on in-person diagnostics, administration or monitoring are more likely to consider delays in commercial launch. Similarly, larger companies with more cash flow security are better positioned to take a longer view on launch timing and may be willing to delay by a quarter or more if they calculate a significant improvement in launch conditions.

Looking at examples of how companies are adapting, Biohaven, who launched an oral CGRP migraine therapy rimegepant right before the pandemic hit the US, are trying to stay nimble and have revamped their marketing tactics through use of webinars, telemedicine, DTC and social media tactics. On April 7, Biohaven announced its recent collaboration with Cove, a telemedicine company, to facilitate remote evaluations for migraine sufferers in lieu of in-office visits and to boost patients’ access to rimegepant. However, despite these efforts, a recent survey noted that neurologists remain hesitant in modifying patients’ migraine treatment regimens and will likely not be utilizing rimegepant due to lack of experience with the product.

In contrast, BMS has taken the decision to delay launching ozanimod for the treatment of relapsing multiple sclerosis. This decision gives BMS a better opportunity to maximise impact of launch, though it also provides existing therapies in the MS market such as Novartis’ Gilenya and Mayzent more time to prepare for the competition.


The impact of the COVID-19 pandemic has undermined months of launch planning, introduced complications and delays into the regulatory process, and severely constricted promotional and educational opportunities for new products. Investment in digital and virtual launch strategies are likely to produce interesting innovations but are unlikely to fully replace in-person channels. This constraint on KOL and prescriber engagement combined with continuing disruption within healthcare practices are likely to dampen interest resulting in sub-optimal launch performance for all but the most innovative new medicines. We anticipate that many new products will attempt to relaunch post pandemic, but the success of such a strategy will vary greatly depending on the specific competitive dynamics.

In the meantime, questions also persist as to supply chain stability and manufacturing prospects for both foreign and domestic drugmakers, given the FDA’s notice that most routine and pre-approval manufacturing facility inspections will be postponed through April. In future commentary on the impact of COVID-19 on the biopharmaceutical industry, Deallus will look to assess the stability of the supply chain, and how manufacturing constraints and shipping of APIs, excipients, and finished drug products may impact companies, payers, HCPs, and patients.

Luke Versten Deallus Senior Associate

Author Luke Versten, Consultant, Deallus New York

Since joining Deallus in 2018, Luke has driven research engagements in immuno-oncology, NASH, and infectious disease treatment areas, where he regularly leverages his knowledge of the space in raising strategic implications for his clients.

Luke supports global stakeholders in making key competitive readiness decisions for pipelines, products, and portfolios by driving strategic assessments, conveying the impact of the latest R&D breakthroughs, and contextualizing opportunity across oncologic, metabolic, and anti-infective therapeutic landscapes. With a depth and breadth of knowledge in basic science, public health, and regulatory policy specific to both chronic and infectious disease, he adds a valuable perspective for clients seeking to realize greater competitive advantage in a variety of contexts. Luke earned an MPH in Epidemiology from Yale University and a BS in Microbiology from the University of Chicago.

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